??? IPLEX for threatment against MMD and ALS - phase 2 trial endpoint in Q2/09 ??? - 500 Beiträge pro Seite

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Ich habe diesen Thread aufgemacht, weil er zielführender ist als der alte, denn Insmed verwendet seine gesamte Energie nun auf IPLEX. Nach dem Merck Deal hat INSM nun zwischen 125 und 135 Mio. USD Cash auf der Hand, bei >120 Mio. Aktien wäre der Cashwert ca. 1 USD. Aktuell stehen wir bei 1,68 USD. Warum werde ich euch erklären:

Das Iplex Phase 2 Trial (MMD) läuft gerade und das 2te Quartal 2009 wird zeigen ob die \"primary endpoints\" erreicht werden. News sind also vorprogrammiert und bis Ende Juni zu erwarten. Ich denke nicht, dass INSM sein Biologics-Portfolio an Merck verkauft hätte würden sie nicht \"good news\" zum Iplex Trial erwarten.
http://seekingalpha.com/article/137584-fda-clinical-trial-up…" target="_blank" rel="nofollow ugc noopener">
http://seekingalpha.com/article/137584-fda-clinical-trial-up…

Insmed Sells Follow-on Biologics Platform to Merck & Co., Inc. for Gross Proceeds of $130 Million / 12.Feb 2009
http://investor.insmed.com/releasedetail.cfm?ReleaseID=36484…

Hier ist etwas aus dem Jahr 2006, zur Geschichte von Iplex, diese Infos sind gut fürs Verständnis:

a. Insmed has a once a day injectable drug approved by the FDA. It is called Iplex. The drug is a combination of igf-1 and bp3. It is approved for small indication - a treatment for very short children that aren\'t helped by growth hormone. It has Orphan Drug Designation.

b. Tercica (TRCA) is a company with a competing drug called Increlex. It is a free igf-1 drug that needs to be injected twice a day. It is approved for the same indication.

c. Essentially the difference between the two drugs is that in all humans there isn\'t a lot of free igf-1 floating around in our bodies. Almost ninety seven percent of igf-1 is packaged together with binding protein 3. Insmed worked out how to synthesize the binding protein with the igf-1.

d. The Iplex combination of igf-1 and bp3 increases the half life of the drug (from one hour to twenty four hours) and decreases the side effects. The main side effect of pure igf-1 and the combination Iplex is hypoglycemia. The difference lies in the levels which one can give the pure igf-1 as against the Iplex drug before the drugs lead to hypoglycemia.

e. In practical terms Iplex only needs to be injected once a day as against Increlex which is injected twice a day. If this drug is injected into a child for five years then the Implex drug saves 1,500 injections. Anyone who has injected a child regularly understands this competitive advantage.

f. Insmed is currently in a trial using the drug for myotonic muscular distrophy. It should work for this indication given that free igf-1 was tried many years ago, and it actually showed efficacy. However patients couldn\'t take the side effects. Insmed should be able to deliver even higher doses, if needed, due to the binding protein. Currently, there is nothing approved for this indication. There are about 40,000 people in the US with this condition and about the same number in Europe.

g. Insmed also has current trials using Iplex in AIDS Lypodystophy and Severe Insulin Resistance.

h. Insmed intends to begin a trial for Noonan’s syndrome and other conditions. There are 270,000 potential patients covering conditions which Insmed can target to deal with including short stature, AIDS, muscular dystrophy and noonans.

i. Two simultaneous battles are occurring between Insmed and Tercica – one in the sales field and one in the courts. Both companies are ramping up salesforces to sell their respective drugs. There is no injunction currently outstanding.

j. Infringement case bought by Genentech and Tercica against Insmed revolves around three patents. Trial before a jury is set to commence on November 6, 2006.

k. It has rarely happened that a safer drug for children would give rise to a total injunction on the product and force it to be withdrawn from the market. Most likely a royalty agreement would be reached. In the interim period, Insmed might have to pay a royalty into escrow until all appeals are completed.

Insmed ist deswegen in aller Munde, weil nicht zuletzt die New York Times einen riesengroßen Artikel über IPLEX (am Sonntag) publiziert hat.

Hier ist der Link:
http://www.nytimes.com/2009/05/17/health/policy/17untested.h…

Auch alle die, die den FDA Calendar beaobachten sind potenzielle Investoren für INSM, da stets regelrechte \"run ups\" erfolgen, wenn eine Biotech Firma wichtige Nachrichten bekannt gibt oder in naher Zukunft bekannt geben wird. Denn wer die DNDN oder VNDA Story gesehen hat, weiss wie groß hier der Hebel und somit der ROI ist.

Auf der Seite seekingalpha.com gibt es zum Beispiel Mike Havrilla der immer auf diese Kandidaten hinweist und Artikel schreibt. Nice Mike.

Hier sind also die neusten News, neben dem Verkauf des Biologics-Portfolio an Merck:

Insmed (NASDAQ:INSM): On 5/13/09, INSM reported its quarterly operating results, including an update on the clinical development of IPLEX, for which the Company continues to expect preliminary Phase 2 results in the treatment of Myotonic Muscular Dystrophy (MMD) during 2Q09. The FDA will also allow Insmed to provide access to IPLEX for investigational use in patients with Amyotrophic Lateral Sclerosis (ALS or Lou Gehrig\'s disease), and the Company will conduct a controlled clinical trial under an Investigational New Drug (IND) application after finalizing the study protocol with the FDA. Insmed also announced that it will received net proceeds of about $125M from the sale of its follow-on biologics (FOB) assets to Merck (NYSE:MRK).

http://seekingalpha.com/article/137584-fda-clinical-trial-up…


Will Insmed\'s IPLEX Meet Expectations?
Insmed Inc (INSM) released its first quarter results last week, which included a $130 million payment from Merck (MRK) that completed the sale of Insmed\'s Follow-on-Biologics (FOB) platform which was agreed to in February. Since news of the sale was announced, INSM has inched higher from the mid forty cent range to close the week at $1.36.

With the sale of the FoB platform to Merck, Insmed will now concentrate on the development and marketing of its primary drug, IPLEX. IPLEX has already been approved by the US Food and Drug Administration (FDA) for the treatment of short stature in children, but due to a patent infringement lawsuit which Insmed lost a couple of years ago, IPLEX is no longer used to treat that indication.

However, as a result of that lawsuit, Ipsen Pharmaceuticals can choose to opt-in as Insmed\'s partner in the development, marketing and distribution of IPLEX if the drug proves effective in treating any other indication in a Phase II trial.

An opt-in on Ipsen\'s part would require that the company issues Insmed a milestone payment and both firms would then share future profits. If Ipsen chooses not to opt-in, Insmed would go it alone, meaning no milestone payment, but also no sharing of profits.

This is why Q2 2009 is a big one for Insmed.

As announced in the Q1 report, preliminary Phase II data in Myotonic Muscular Dystrophy (MMD) should be released 2Q 2009, before the end of June.

If the results are positive, Ipsen may decide to opt-in, providing Insmed with an additional cash infusion that will alleviate the need to raise capital for quite some time. If Ipsen chooses not to opt-in, Insmed will be in pretty good shape anyway because the Merck payday will allow them to fund future operations, including a Phase III, without the threat of needing to raise cash anytime soon.

The only way Insmed loses is if the results do not meet expectations.

If results are positive, the Insmed stock could breach the $2.50 mark, or higher, based on the potential of IPLEX. The trading pattern of INSM over the past couple of weeks has me believing that news is imminent, and I do not believe that the recent rise to $1.50 is strictly the result of the pending quarterly report.

Also, if Insmed management were not confident in the development of IPLEX, I do not believe that they would have sold their FoB platform, a potential lucrative market once Congress enacts regulation of that market, as expected. In my opinion, the sale of the FoB pipeline is bullish for the company.

In addition to MMD, IPLEX is also being investigated to treat ALS and other indications.

Based on the fact that IPLEX is an already FDA-approved drug with huge potential, I believe INSM is a five dollar stock right now. If quarter two produces solid Phase II MMD results and any additional good news, I would expect to the stock reach that level by mid summer (give or take) as the economy rebounds and money pours back into the market.

http://seekingalpha.com/article/138180-will-insmed-s-iplex-m…

Hier ist eine Liste der Institutionellen Investoren:
http://www.mffais.com/insm

Hier könnt ihr den Kurs verfolgen:
Symbol: INSM
http://www.level2stockquotes.com/level-ii-quotes.html


Viel Spaß.
Der Verfasser ist zu 1,2x in INSM investiert.

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Fighting for a Last Chance at Life

Article Tools Sponsored By
By AMY HARMON
Published: May 16, 2009

VIRGINIA BEACH — As Lou Gehrig’s disease sapped Joshua Thompson of his ability to move and speak last fall, he consistently summoned one question from within the prison of his own body. “Iplex,” he asked, in a whisper that pierced his mother’s heart. “When?”

Iplex had never been tested in people with amyotrophic lateral sclerosis, the formal name for the fatal disease that had struck Joshua, 34, in late 2006. Developed for a different condition and banished from the market by a patent dispute, it was not for sale to the public anywhere in the world.

But Kathy Thompson had vowed to get it for her son. On the Internet, she had found enthusiastic reviews from A.L.S. patients who had finagled a prescription for Iplex when it was available, along with speculation by leading researchers as to why it might slow the progressive paralysis that marks the disease. And for months, as she begged and bullied biotechnology companies, members of Congress, Italian doctors and federal drug regulators, she answered Joshua the same way:

“Soon,” she said. “Soon.”

At a time when terminally ill patients have more access to medical research than ever before, and perhaps a deeper conviction in its ability to cure them, many are campaigning for the chance to be treated with drugs whose safety and effectiveness is not yet known.

But even as advances in areas like stem cells and genetics generate greater hope for experimental therapies, there is little consensus on how and when to provide them to dying patients whose lives could be prolonged, or shortened, by trying them.

Insurance companies typically do not pay for drugs that are part of a not-quite-finished scientific process. But even affluent families like the Thompsons find themselves pleading simply for the right to buy a drug, with institutions and individuals that often seem to them to have no logic — and sometimes no heart.

Doctors worry about instilling false hope and doing unnecessary harm. Companies fear damaging a drug’s chance of winning approval from the Food and Drug Administration if a patient suffers a bad reaction. The F.D.A. itself does not want patients to bypass clinical trials, which require that some participants receive a placebo to determine reliably whether a drug works.

Some patient advocates are lobbying for laws and policies that would sanction what has become known as the “compassionate use” of experimental drugs by seriously ill patients who have run out of other options. But for now, each appeal to the guardians of untested drugs is an improvisation, in which success relies on connections, determination, mercy and luck, and the hope of prevailing can sometimes eclipse the hope held out for the drug itself.

The Search for a Treatment

Kathy discovered Iplex deep in the pages of her first Google search for “A.L.S. and treatment” late one night in spring 2007, shortly after Joshua’s diagnosis.

In the daylight, she still had trouble believing that her athletic, magnetic son had the devastating disease with an unknown cause, named for the 1930s New York Yankees star whose career was cut short by it. When Joshua’s racquetball racket flew out of his hand because he could not grip it, his mother’s diagnosis was tennis elbow. When the first neurologist mentioned A.L.S., she scheduled more tests, rooting for Lyme’s disease, multiple sclerosis or even cancer.

But an A.L.S. specialist at Johns Hopkins University, Dr. Jeffrey D. Rothstein, had confirmed it. Like the 5,600 other people given the diagnosis each year in the United States, Dr. Rothstein said, Joshua would almost certainly die of the disease in two to five years.

The doctor prescribed the only drug approved for A.L.S., Rilutek, which typically prolongs life by a few months. Joshua, he said, would be eligible to participate in a clinical trial for another drug, Arimoclomol, that would start as soon as the F.D.A. gave the go-ahead. There was nothing else.

Except, maybe, Iplex.

Kathy clicked her way through online news releases, blogs and scientific journal articles. Iplex, she learned, is believed to protect the motor neurons whose death leads to paralysis in A.L.S. Some patients had persuaded their doctors to prescribe the drug when the F.D.A. approved it in late 2006 for children with growth deficiencies.

“I started on Tuesday,” Debbie Gattoni, an A.L.S. patient in New Jersey, had written on a Web discussion forum, “and on Sunday, I noticed that my right index finger, which was bent, was straightening and moving on its own.”

But almost immediately, the drug’s maker, Insmed, lost a patent infringement lawsuit to a biotechnology firm that was already selling a drug for short stature that had similar properties. Iplex , however, was thought to be more potent for treating A.L.S.

Insmed agreed to pull its drug off the market. Only the Italian Health Ministry, which had begun to distribute the drug to A.L.S. patients under a compassionate use program, could continue to buy it.

Kathy dashed off a letter to the F.D.A.

“Is there any way we can get Iplex,” she wrote, “before it is too late for my son and others like him?”

But the agency could not weigh in until Insmed agreed to make the drug available. And Insmed’s hands were tied by the settlement agreement.

Mounting Physical Needs

In late July, Joshua fell in the street near Times Square on a trip to New York with his wife, Joy, and could not get up. Joy could not lift him, and passers-by did not stop. Finally, a homeless person watching from the corner came to help.

The event was traumatic for Joshua, who was beginning to experience another symptom of the disease, too, a lack of control over his emotions. At the weekly poker game with his friends, he could no longer bluff.

As Joy helped Joshua with his mounting physical needs and cared for their son, Wyatt, who had been born two weeks after Joshua’s diagnosis, the couple pressed Kathy to explore Joshua’s medical options.

They decided he should try what seemed like the next best thing to Iplex — the drug that had triumphed over it in the patent dispute. But the first neurologist they visited refused to give him a prescription.

“This could cause hypoglycemia,” he told Joshua, warning that low blood sugar could result in seizures or brain damage.

“I’ll take my chances of hypoglycemia over laying in the gutter,” Joshua replied fiercely, but the doctor did not relent.

Kathy found another doctor to prescribe the drug, called Increlex. But she cried later when she read a blog entry by an A.L.S. patient who said he had experienced a “seismic” improvement on Iplex before it was withdrawn. The Increlex shots he was taking now felt like “trying to get drunk on cough syrup when there’s a case of bourbon locked in the closet,” he wrote.

At brunch with her long-term boyfriend, Richard Stravitz, soon after, Kathy told him she did not want to play golf that afternoon, as was their Sunday ritual. As always these days, she could think only about trying to help her son.

“I understand,” she said, “if you need to move on.”

Mr. Stravitz, a sculptor and retired chairman of the meat processing giant Boar’s Head Provisions, shook his head.

“I want to help,” he said.

Involuntary twitches known as fasciculations signaled which of Joshua’s muscles would be the next to go. His mother watched the disease spread from his right arm to his left arm to his left leg. A natural storyteller who had played toastmaster at friends’ weddings and charmed business associates with stories of his misadventures in surfing and snowboarding, Joshua began to slur his words in what is known as the “A.L.S. accent.”

Kathy, who had majored in biology before leaving college when she was pregnant with her son, ruled out traveling to Belize or China for stem cell infusions with no proven value. But she did pay $25,000 to send Joshua to a holistic health program in Arizona for a month. At the clinic, he had physical therapy and swallowed vitamin cocktails. He spent hours each day hooked to an intravenous tube to remove heavy metals from his body. But any improvement quickly dissipated on his return.

A few weeks later, the cancellation of the clinical trial that Joshua had been waiting to participate in came as a sharp blow. The F.D.A., the Thompsons were informed, wanted more animal research first.

“We have to get Iplex,” Kathy told Joshua’s father, Bruce Thompson. “I’m going to find a way.”

Divorced 20 years earlier, the Thompsons still sometimes shared holidays and vacations with Joshua and their younger son, Christopher, but they disagreed on how to approach A.L.S. Bruce had concluded there was little to be done medically. He proposed a trip to Europe, where Joshua had never been.

A hotel and restaurant developer who had been training his older son to someday take over his business empire, Bruce remodeled his guest house, where Joshua and his family had moved, to make it wheelchair accessible. And in December, tracing Joshua’s irritability and depression to the cycle of raised and dashed hopes, he admonished Kathy not to mention to their son what seemed like an impossible long shot.

“Let him live his life,” Bruce urged her in a heated conversation. “Don’t give him false hope.”

“This isn’t false hope,” Kathy retorted. “It’s real. And it’s all we have.”

Joshua did not go to Europe. But in February, he and Joy told their inner circle and that Joy was pregnant with their second child. Wyatt, the couple had decided, should have a sibling.

On hearing the unexpected news, one family friend gave Joshua a fist-bump.

“I didn’t know you could do that,” he said.

Joshua laughed.

“It seems to be the only thing that’s still working,” he replied.

‘Our Rights to Live’

Adopting the online moniker “FightingMom,” Kathy haunted Web forums devoted to the disease. At night, after working full days at her own business, which manufactures filling for quilts, she exchanged messages with several dozen patients and caregivers who came to call themselves “Team Iplex.”

“Fighting Mom,” wrote Andrea Reimers, a nurse who was pursuing Iplex for her husband, Jim. “It seems to me that there haven’t been enough cries from the A.L.S. community to demand our rights to live.”

Mrs. Reimers thought a demonstration by dying people in wheelchairs might shake up the companies holding Iplex under wraps.

Her militancy emboldened Kathy, whose letters and calls to public officials took on a more insistent tone. But everyone told her it was a corporate matter.

She also turned her attention to Italy, where the government was still spending several million dollars a year to buy Iplex for A.L.S. patients. A doctor there wrote to Kathy that she had seen “very good results in almost 50 percent” of the A.L.S. patients she had treated with Iplex over two years. Joshua and Joy were ready to move there, but the answer came back: only Italian citizens could receive Iplex through the program.

“Josh’s sadness is unbearable,” his mother wrote one night in her journal, nearly a year after her son’s diagnosis.

Unexpected encouragement came in a Mother’s Day note from her ex-husband. “You have given me some peace of mind that all potential options for Josh are being researched and acted upon,” Bruce wrote. “Thank you.”

Kathy’s boyfriend accompanied her to Insmed’s headquarters in Richmond, Va., offering to raise several million dollars to underwrite a compassionate use program for Iplex in the United States with A.L.S. patients. But the couple came away with a new understanding: F.D.A. regulations, they were told, prohibit any company from profiting on compassionate use. Even if Insmed could wriggle free of restrictions in the patent agreement, there was little financial incentive for it to invest in making the drug solely for compassionate use by A.L.S. patients.

Kathy was not surprised when weeks passed without hearing back.

Seizing an Opening

By July, Joshua could no longer lift his arms. Feeding him one evening, Kathy stifled a cry when she saw his tongue twitching as if it had large worms crawling inside it. Worse for her was the knowledge that he had felt the fasciculations, and known what they signaled: the end of swallowing, saliva control and speech.

“I can’t believe I may never hear him speak again,” she wrote in her journal.

The best hope for regenerating the long nerves that control muscle movement, Kathy knew, were stem cell therapies still in very early stages of development. But if Iplex worked as hoped, it would slow the death of those nerves, perhaps sustaining Joshua’s life long enough for a cure to come along.

That fall, a major study at the Mayo Clinic concluded that a hormone that is the active agent in Increlex and Iplex had no effect on people with A.L.S. But a leading researcher suggested that a drug like Iplex, which combined the hormone with a protein that could deliver it to cells more effectively, could have better results.

Kathy saw an opening. Genentech, the company that held the patent for Increlex, would now most likely have no market for its own drug among A.L.S. patients. Perhaps it would release Iplex from the restrictions of the patent settlement.

Aggie Wilson, the assistant who answered Kathy’s call to Genentech’s chief executive, listened to her story.

“His son keeps sitting on his lap saying ‘Hello, Dada,’ waiting for Josh to say hello,” Kathy said of Wyatt.

Ms. Wilson told Kathy that if she wrote a letter, she would personally deliver it to her boss.

Kathy did not wait for his response. The members of Team Iplex set a date for the protest: Veterans Day, at the Capitol in Washington. They let the drug companies know that dozens of news media outlets had been alerted.

Joy gave birth to a boy, Jordan, a few weeks later. And at the urging of his mother and his wife, Joshua assented to using a machine that enabled him to communicate with a speech synthesizer. A camera picks up small movements of his head as he “types” letters on a screen, tracking a reflective patch on his forehead.

Kathy and Joy watched him laboriously peck out his first words, anticipating an expression of gratitude or affection. Instead, the machine pronounced a playfully vulgar directive. Gleeful, Joshua hit the “repeat” button over and over.

The Saturday evening before the protest, Kathy found a letter in her e-mail. The competing companies had agreed to make Iplex available to A.L.S. patients worldwide on a compassionate use basis, pending the approval of the regulatory agencies.

On a crisp fall day, on the lawn outside the Capitol, Team Iplex handed out information about the disease, and celebrated. All they needed now was for their doctors to file a formal request for the drug with the F.D.A.

Safety Concerns

Joshua’s doctor at Johns Hopkins, Jeffrey Rothstein, believed there was a rational logic for why Iplex might work. But the review procedure at Hopkins, he told Kathy, could delay getting the request to the drug agency. Instead, Kathy took the stack of paperwork to her son’s local family practitioner, Dr. David L. Werwath, only to burst out crying in his office when he demurred.

He had never treated anyone with A.L.S., much less with an experimental drug.

But that evening, he called Kathy on her cellphone to tell her he had had a change of heart.

“Look, I’m a father,” he said “If it were my son or daughter, I’d be doing the same thing.”

The F.D.A. had a month to respond from the date it received Joshua’s application on Dec. 16. When Joshua asked about Iplex now, Kathy told him, “It should be any day.”

On Jan. 16, when Dr. Werwath called to tell her the application had been rejected, she stood up in disbelief.

“How could that be?” she asked, dazed.

Kathy’s friend Mrs. Reimers had received a call with the same news.

“He said they had safety concerns,” Mrs. Reimers said. “This for a drug that was approved for children!”

“Safety,” Kathy repeated. “And what, exactly, is safe about A.L.S.?”

Appealing an F.D.A. Denial

Before the F.D.A.’s decision, Kathy had spared little thought for any broader meaning of her quest for Joshua. But when she met with Richard A. Samp, a lawyer with the Washington Legal Foundation a week later, her outrage went beyond her son, and beyond Iplex.

“The F.D.A. is supposed to protect American citizens,” Kathy fumed over an iced tea in Williamsburg, Va. “How does denying dying patients access to this drug serve the common good?”

Mr. Samp had handled a lawsuit by a patient advocacy group, the Abigail Alliance, that had sought to establish a constitutional right for terminally ill patients to use experimental drugs. In the case, which the group had lost on appeal in 2007, the F.D.A. claimed that it granted “nearly all” requests for compassionate use.

They would first make an administrative appeal, Mr. Samp told Kathy, asserting that the F.D.A. had violated its own guidelines. If that failed, they could pursue litigation that might allow them to raise the constitutional question again in a federal court in Virginia.

“But,” he said carefully, “that might continue for a number of years.”

Because a lawsuit cannot continue if the plaintiff dies, Mr. Samp explained that it might require forming an organization to carry it forward.

Kathy stirred her iced tea.

“I’d like to do that,” she said finally. “This case could be important to lots of patients, even if Josh is no longer involved.”

In its follow-up letter, the F.D.A. had indicated that its chief concern was that “adequately controlled trials would become virtually impossible” if it granted requests like Joshua’s. In the appeal, Mr. Samp argued that Joshua and other A.L.S. patients, whose life expectancy was measured in months, would never have an opportunity to participate in such a trial.

Kathy had avoided telling her son that the drug agency had turned them down. His swallowing had deteriorated to the point that he choked after just two sips of an Orange Crush soda he asked his mother to bring him one night. When he finally agreed to have a feeding tube inserted in mid-February, his family viewed it as a statement that he wanted to live. But the tube also represented a new frontier in the heartbreak of A.L.S., which took away small pleasures every day, and sometimes big ones.

“How cruel can you be?” Bruce barked at his younger son, Christopher, when he unwrapped a hoagie in front of Joshua.

Mr. Samp’s foundation, a conservative public interest law firm, had agreed to work on the appeal pro bono for members of Team Iplex. Kathy tried to interest Andrea Reimers in joining her appeal. But after learning of the drug agency’s decision, Mrs. Reimers said, her husband went into respiratory distress and now could barely breathe.

He died on Valentine’s Day.

Winning a Reversal

Kathy was pouring milk for her cereal on the morning of March 10 when Dr. Werwath’s number flashed on her phone. The F.D.A. had just reversed itself, he said.

Before she could take a breath, Senator Mark Warner’s office called. E-mail bleeped in as the news seeped out.

In the weeks after the appeal, Kathy learned, the F.D.A. had reached out to Insmed. The agency had persuaded the company to run a clinical trial for Iplex with several dozen A.L.S. patients, and permitted it to recoup the hefty costs directly from participants. In the trial, some of the participants would get a placebo. That way, the F.D.A. wrote on its Web site, the next wave of A.L.S. patients would learn whether the drug was in fact beneficial or harmful.

But for now, the agency had ruled, Joshua and 12 other patients would be given Iplex outside of the trial, on a compassionate use basis, if they agreed to read all the data about the risks.

Who would pay for the drug, which Insmed said could cost $100,000 a year, was unclear.

Kathy called her daughter-in-law Joy and asked her to turn the speakerphone on. She reported the news, and smiled to hear Joy tell her that Joshua had raised his eyebrows, his sign of approval. Then she sat down at her kitchen table and gazed out at the ocean.

“Oh my gosh,” she thought for the first time. “What if it doesn’t help him?”

Dr. Werwath arrived with Joshua’s first vial of Iplex at 9:10 a.m. on Wednesday, March 25.

The doctor slipped on his gloves and showed Kathy and Joy how to extract the medicine with a needle. Then the women followed the doctor into Joshua’s bedroom and watched him give the injection, which one of them would do daily.

Joshua slept most of the day.

But when Kathy visited a few days later, her son was sitting in a reclining chair in the living room, in good spirits. They watched the end of a college basketball game together. Around 11:30 the original “Airplane” movie came on.

Joshua smiled a lot. It made her smile too.

•

EPILOGUE: In April, Joshua signaled that he felt he was swallowing better, and to Joy and Kathy he seemed to be regaining tone in his voice. But on Easter Sunday, he was rushed to the hospital with pneumonia and is still on a ventilator. He continues to take Iplex every day. c nytimes

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Biogenerics platform was sold in february 2009 to Merck for 130 million US dollars (finalizes march '09)

- Total share count for Insmed: 122 million, cash per share from the deal: 1.03$ per share after taxes
( Proceeds for Insmed are 123 million US dollar AFTER taxes )
- Liabilities end of 2008 6~8million, 2.4 million in cash
- Cash burn was about 1 million per month prior to the Merck deal
- Tax los carry forward per dec '07 330 million US dollars.
- 70 staff will go with the Boulder plant to Merck (of total of 90 TOTAL staff for insmed)
- 20 staff will remain at Insmeds Richmond HQ.
- IPLEX pipeline and IP remain
- IPLEX is allready fda approved for short stature in children
- IPLEX is researched in europe in retinophathy in infants.
- IPLEX Myotonic Muscular Dystrophy IIb resuls in Q2 the latest (peak revenue estimates from 600mln-1.3bln)
- MMD iib results triggers optin from ipsen/genentech (50% of all past and future cost in return for 50% of profits)
- ALS (Lou Greg) named patient partner to be announced soon
- Still takeover candidate for Ipsen and/or Genentech

march 2008 CFO comment: (MMD trial will go to phase III in Q2, despite that...) " In the short-term, we expect to be cash neutral for the balance of 2009 as we continue moving ahead with our IPLEX(TM) programs for MMD and ALS. "

c finance.yahoo.com

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march 2009 CFO comment: (MMD trial will go to phase III in Q2, despite that...) " In the short-term, we expect to be cash neutral for the balance of 2009 as we continue moving ahead with our IPLEX(TM) programs for MMD and ALS. "

Italian data on iplex in ALS from march 2009 : In 25% of these patients, on-treatment ALSFRS-R values either did not change over time or slightly increased.

http://investorshub.advfn.com/boards/board.aspx?board_id=143…

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2) Expansion of their lead fda approved drug IPLEX,
(Additional research into the proven potential of the ifgbp3 binding protein in anti cancer treatments.)
-Expanded acces program compassionate use in italy for ALS. mandatory reimbursement by governement through fixed legal pathway.
-Opt in agreements with trca (now Ipsen) and genentech for reimbursement of 50% of all past cost upfront and 50% of all future cost upon completion of phase IIb data.

Insmeds main pipeline drug IPLEX, multiple uses are being investigated, most noteworthy:
MMD - myotonic muscular dystrophy
ALS - Amyotrophic lateral sclerosis (ALS, sometimes called Lou Gehrig's Disease
ROP- Retinopathy of prematurity, a condition of the eyes causing blindness (european trials run by Premacure (sweden))

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Leute ich brauch hier UNTERSTÜTZUNG, INSM kann sich bis ende juni verdoppeln, soll ich hier (im falle positiver daten) alleine feiern? soll ich den ganzen kram übersetzen?

[Indium]

Antwort auf Beitrag Nr.: 37.214.495 von [KERN]Codex am 20.05.09 00:14:39

@KERNCodex, ... 100% bis Juni, dann wäre ich fast 400% im Plus .
Grüsse an alle die geschlafen haben und immer noch schlafen

[[KERN]Codex]

Mein Ziel sind erstmal 100% und dann sehen wir weiter, News sind angesagt und wir haben EIN GUTES MANAGEMENT, das ist alles was zählt! Gruß

[[KERN]Codex]

Ich hoffe hier gibts noch mehr Investoren, zu zweit wirds hier schnell langweilig und Monologe möchte ich auch nicht führen..

[[KERN]Codex]

MACD kurz vorm Kaufsignal - wenn die 1,80 USD gebrochen werden gehts schnell auf über 2 USD.

[[KERN]Codex]

Hier gibt es viele Links und Erfahrungsberichte:

http://www.disabled.gr/forum/showthread.php?s=09792e5a1c981a…

Und noch eine Frage an Euch (zur Diskussionsanregung):

Wie seht ihr das mögliche opt-in von Ipsen (Mutter von Tercia). Es geht um 50% der Profits und auf der anderen Seite der Kosten. Wenn die MMD Phase IIb Trial Daten, die bis ENDE JUNI erwartet werden, positiv sind, dann könnte sich IPSEN entscheiden IPLEX zusammen mit INSM herzustellen und zu vermarkten..

Hintergrund ist der Patentstreit zwischen Genentech, Insmed und Tercia (IPSEN). Dieser wurde Anfang 2007 beigelegt.

Hier der Link zum settlement:
http://www.drugs.com/news/insmed-announces-restructure-settl…

Hier ein umfangreicherer Artikel:

Tercica and Genentech Settle Infringement Suit Against Insmed


by Stephen Albainy-Jenei
March 8, 2007

In 2004, Tercica, a licensee under a Genentech patent for a growth hormone, filed suit against Insmed in the U.K. alleging infringement of EP patent No. 571,417, or the ‘417 patent. The ‘417 patent has claims directed to particular uses of a combination of IGFBP-3 and IGF-1. In the complaint, Tercica asked the court for an injunction to restrain allegedly infringing activity, for a declaration that the ‘417 patent is valid and infringed, for an order requiring the delivery or destruction of allegedly infringing articles and materials and for an inquiry into possible economic damages.

In addition, Genentech and Tercica sued Insmed for infringement of U.S. Patent Nos., 5,187,151 (‘151 patent) and 6,331,414 (‘414 patent) in the U.S. District Court for the Northern District of California. These patents are directed to certain methods of using rhIGF-1/rhIGFBP-3 and methods of producing rhIGF-1, respectively.

On February 16, 2005, Tercica filed an amended complaint, adding an infringement allegation against Insmed with respect to U.S. Patent No. 5,528,287, or the ‘287 patent. The claims of the ‘287 patent are directed to DNA encoding BP53 (i.e. IGFBP-3) and recombinant constructs, transformed host cells and methods for using the same. Genentech and Tercica claimed that the production or use of IPLEX, a complex of rhIGF-1/rhIGFBP-3, would infringe these patents and that the infringement was willful.

The court found that Insmed Incorporated and Insmed Therapeutic Proteins, Inc. infringed the ‘287 patent; willfully infringed the ‘151 patent; and upheld the validity of the ‘414 patent. Tercica exclusively licensed these patents in April 2002 for use in its manufacture and sale of, among other things, Increlex. Prior to the trial, the Court had ruled that Insmed’s process for making the IGF-1 in IPLEX literally infringes three claims of the ‘414 Patent, and Insmed had stipulated that it infringes on three additional claims.

The jury verdict ordered Insmed to pay $7.5 million and 15% royalties for damages pertaining to IPLEX past sales of up to $100 million, and 20% royalties for IPLEX past sales greater than $100 million.

Genentech and Tercica have now resolved their litigation against Insmed in both the US and the UK in a settlement of the patent infringement and unfair business practices suits brought against Insmed.

In parallel, the companies announced that they have entered a license and development agreement in order to end the dispute, while Tercica and Genentech have waived the damages awarded by the jury in the US patent infringement litigation.

Under the terms of the settlement, Insmed will no longer provide Iplex to patients with severe Primary IGF-1 deficiency and other short stature indications and will withdraw its Iplex marketing application in the EU. Insmed will have freedom regarding manufacture, development and commercialisation of the drug for certain non-short stature indications, subject to opt-in rights and royalty provisions for Tercica and Genentech, the companies said.

Furthermore, the parties will form a joint-development committee to guide the development and commercialization of Iplex in non-Tercica/Genentech indications. The Settlement, License and Development Agreement is in effect until the later of 2018 or the expiration of any subsequent Tercica/Genentech issued patents that cover IPLEX or its indications.
http://www.patentbaristas.com/archives/2007/03/08/tercica-an…" target="_blank" rel="nofollow ugc noopener">
http://www.patentbaristas.com/archives/2007/03/08/tercica-an…

Ich denke wenn die Daten aus Phase IIb MMD positiv sind, wird Ipsen bei Insmed einsteigen und nochmal ordentlich Cash reinpumpen.

[[KERN]Codex]

Ich erwarte also mindestens 3 News in den kommenden Wochen:

bis Ende Juni:
-MMD Trial PII results
-Ipsen opt-in
-Start Phase III
(-ALS named patient update)

[[KERN]Codex]

Ziel kurzfristig 4-5 USD. Aktuell 1,67 USD. Halten wir das fest!

[[KERN]Codex]

-125 mln cash
-280 mln tax carryforwards (das hatte ich noch garnicht bedacht)
=> deswegen haben die auf den merk deal auch so wenig steuern bezahlt (nahezu keine)
-18 employees
-annual sales prediction mmd + als + rop >1 Mrd. USD
-multiple news coming up
-technisch auf kauf (siehe chart)
-in den medien (nytimes, indiatimes)
-unmet clinical need
-übernahme ziel

Und ich bin hier immernoch alleine, das gibts nicht.. es wird nicht billiger Leute.

[[KERN]Codex]

Hier der Realtime Chart und jetzt werde ich nicht mehr posten bis News kommen oder jemand anders seinen Senf dazugibt!

[dyna6]

Antwort auf Beitrag Nr.: 37.264.318 von [KERN]Codex am 27.05.09 17:15:35

Hey und danke für Deine ausführlichen Berichte. Ich bin selber investiert und weis deine Mühe sehr zu schätzen aber leider fehlt mir einfach die Zeit mich an der Diskussion zu beteiligen aber teile Deine Meinung das uns ihr bald sehr positive Nachrichten präsentiert werden. Also schreib bitte weiter wenn es Deine Zeit zu lässt denn hier gibt es viele interresierte Leser und die Zahl wird glaub bald massiv ansteigen. Mein persönliche Kursziel für Ende 2009 falls alles so eintrifft wie es sich Insmed vorstellt sind 8 USD.

[Indium]

!

Dieser Beitrag wurde moderiert. Grund: auf eigenen Wunsch des Users

[Indium]

!

Dieser Beitrag wurde moderiert. Grund: Korrespondierendes Posting wurde entfernt

[[KERN]Codex]

After Hours: 1.74 Up 0.02 (1.16%) 4:02pm ET

[orfmen]

Antwort auf Beitrag Nr.: 37.262.579 von [KERN]Codex am 27.05.09 14:53:34

Hallo Kerni,
ich dachte ich schau mal kurz rein.
Wenn ich ein wenig Kritik üben darf.
Du hast hier sehr viel schönes Material zusammen gesammelt und auch ein persönliches Ziel definiert...Ziel kurzfristig 4-5 USD. Aktuell 1,67 USD. Halten wir das fest!
...
Leider verliert man hier schnell den Blick für das Wesentliche.
Kannst du nicht mal eine kleine Zusammenstellung, wenn möglich auf Deutsch , für "Blitzmerker" wie ich es bin, zusammenstellen.
Wichtig wären dabei,
-die Kandidaten, wie weit sind sie
-wann wäre Marktzulassung möglich, dafür geschätzte Peaksales
-Auszug aus erfolgreichen Studienverläufen, soweit vorhanden
-warum soll die Technologie so einzigartig sein, Vorteil gegenüber Wettbewerb
-verdient man schon Geld, Lizenzen.....
-Auszug aus Analystenmeinungen (wenn möglich auch deutsch) usw.
-alles was sonst noch die Einzigartigkeit des Unternehmens klarmachen könnte

Zugegeben, macht etwas Mühe, aber es muss nicht ein Buch werden.
Kurz und knapp, alles auf deinem Rechner abgespeichert, so ist es sofort verfügbar und ständig erweiterbar.

Man kann hier als "Ausländer" zwar grob den Sinn herauslesen, aber die wichtigen Feinheiten müsste man sich erst mit Mühe erarbeiten, da hört es dann schon bei vielen auf. Wenn das einer übernimmt und hier reinstellt, haben viele etwas davon. Dafür wird dir zwar nicht gedankt, aber man wird auf diesen Wert aufmerksam und hat eine gute Diskussionsgrundlage.

Du wirst sehen, es wird helfen!
Zumindest ist es einen Versuch wert. Vielleicht überzeugst du dann sogar so einen alten Holzkopf wie mich!

Der Verfasser ist zu 1,2x in INSM investiert.
Das habe ich ja noch nie gehört, wieviel soll das sein. Das 1,2x fache deines Vermögens, auf Kredit???

Viel Erfolg!
Grüße!

[[KERN]Codex]

+++Einleitung: Um was geht es hier eigentlich?+++

Es geht hier die Wachstumshormone IGF-1 und IGFBP-3. Diese sind essentiell für das Wachstum von Knochen, Muskeln und Nervenzellen.

Sowohl IGF-1- als auch IGFBP-3-Spiegel sind altersabhängig: am niedrigsten sind die Werte bei der Geburt, sie steigen in der Kindheit kontinuierlich an mit Maximalwerten in der Pubertät und fallen im Erwachsenenalter allmählich wieder ab.

Iplex ist eine Kombination dieser Faktoren. (IGF= insulin-like growth factor)

Das Medikament IPLEX (mecasermin rinfabate) ist eine pharmakologische Substanz, die von der Firma INSMED die Behandlung der kindlichen Wachstumsstörung entwickelt wurde, welche durch einen primären IGF-1-Defekt verursacht wird. IPLEX ist pharmakologisch dem IGF-1 verwandt, das ein wichtiges Wachstumshormon darstellt. Aufgrund von patentrechtlichen Auseinandersetzungen wurde IPLEX zur Behandlung der Wachstumsstörung vom Markt entfernt, jedoch als potentiale Behandlungsoption bei verschiedenen Erkrankungen weiter diskutiert. So findet derzeit eine klinische Studie an der Universität Rochester (USA) zur Behandlung der myotonen Muskeldystrophie (MMD) mit einer täglichen subkutanen Injektion von IPLEX statt.

Im menschlichen Körper ist IGF-1 mit dem bindenden Protein IGF-3 (IGFBP-3) verbunden. Insmed ist die einzige Firma weltweit, die in der Lage ist, eine Kombination aus diesen beiden Medikamenten herzustellen. Es ist wissenschaftlich erwiesen, dass IGFBP-3 IGF-1 wesentlich länger im Körper bewahrt als freier IGF-1, so dass eine einmalige Behandlung am Tag ausreichend ist. Dieser längere Verbleib im Körper ermöglicht auch, dass IGF-1 die beabsichtigen Ziele im Körper erreicht, indem es anscheinend die Blut-Hirn-Schranke überwindet und somit die größtmögliche Chance hat, bei ALS-Patienten Neuronen zu schützen, neues Wachstum zu fördern und beschädigte Zellen zu reparieren. Iplex wurde in den USA bereits von der Arzneimittelzulassungsbehörde FDA zur Behandlung von Kleinwüchsigkeit (=short stature) zugelassen.

In den USA befindet sich Iplex gerade in Phase 2 einer Placebo-kontrollierten Studie zur Behandlung der Myotonen Dystrophie (MMD). Die Ergebnisse bisher zeigen, dass Iplex schwache Muskeln stärkt, die Magen-Darm-Funktion, die Ausdauer beim Gehen sowie kognitive Funktionen verbessert, während es auch die Schmerzen, die mit dieser Krankheit verbunden sind, lindert.

Italienische ALS-Patienten (ALS = amyotrophic lateral sclerosis), die Iplex seit eineinhalb Jahren bekommen, berichten ebenfalls über erhebliche Verbesserungen ihres Zustands. Weitere Patienten versuchen, in das in Italien existierende Erweiterte Zugangsprogramm (named patient program) zu Iplex zu gelangen, das von Insmed in Zusammenarbeit mit Cephalon und dem italienischen Gesundheitsministerium durchgeführt wird. Einige US-Amerikaner, die kurzzeitig Zugang zu Iplex hatten, berichten ebenfalls schnelle Verbesserung ihres Zustandes. Als-Patienten in
der ganzen Welt verdienen die Möglichkeit, Iplex selbst zu bekommen und zu sehen, ob es das erreicht, was bisher keine andere Behandlung erreicht hat: die substantielle Verlangsamung der Progression von ALS und möglicherweise sogar die Wiederherstellung von bereits verloren gegangenen motorischen Funktionen.

Es ist vielfältig einsetzbar und alle warten auf die MMD PIIb Daten. MMD = myotonic dystrophy

Symptome: Meist macht sich als erstes eine Muskelschwäche im Bereich des Becken- und auch des Schultergürtels bemerkbar. Häufig sind zum Beispiel bei Erstbefall der Beinmuskulatur Schwierigkeiten beim Treppensteigen oder Aufrichten aus einem tiefen Stuhl, bei Befall der Armmuskulatur Probleme beim Heben der Arme, etwa beim Haarekämmen. Die Muskulatur ist oft zumindest zeitweilig schmerzend und druckempfindlich. Die Schmerzhaftigkeit wird vor allem in der Tiefe der großen Arm- und Beinmuskeln angegeben und als überstarker; bzw. nicht durch entsprechende Belastungen erklärbarer Muskelkater geschildert, sie verstärkt sich unter Belastungen. Trotz der entzündlichen Ursache sind jedoch Muskelschmerzen kein regelmäßiges Symptom dieser Erkrankung, bei akuten Formen findet man sie häufiger, bei chronischen Stadien können sie völlig fehlen. In schweren Fällen kommen zusätzlich Schluckstörungen oder sogar eine Atemschwäche hinzu. Neben der Muskulatur können auch andere innere Organe insbesondere der Herzmuskel, betroffen sein. Bei der Dermatomyositis werden die Muskelsymptome von einem Hautausschlag begleitet. Es handelt sich hierbei im frischen Stadium um rötlich-bläuliche, oft ausgesprochen lilafarbene Hautverfärbungen an charakteristischen Stellen, zum Beispiel an den Augenlidern, Wangen, am Hals, am vorderen Brustkorb oder an den Streckseiten von Armen und Beinen.

Nach heutiger Kenntnis gehören die nicht erregerbedingten entzündlichen Muskelerkrankungen zu den Autoimmunerkrankungen. Bei diesen Krankheiten attackiert das Immunsystem, dessen eigentliche Aufgabe in der Abwehr und Bekämpfung körperfremder Krankheitserreger besteht, sozusagen irrtümlich eigenes Gewebe. Bei der Dermatomyositis richtet sich dieser Angriff wahrscheinlich in erster Linie gegen kleine, für die Ernährung von Haut und Muskel wichtige Blutgefäße. Das bedingt eine sogenannte Vaskulitis, das heißt eine im Gewebe unter dem Mikroskop erkennbare Entzündung in diesem Bereich. Durch die dadurch bedingte Beeinträchtigung der Blutversorgung werden Haut und Muskeln indirekt geschädigt.

IPLEX auch bekannt unter dem Namen mecasermin rinfabate bei Wikipedia (teilweise veraltet):

http://en.wikipedia.org/wiki/IPLEX


Marktpotenzial:
Blockbuster Status - siehe externe Marktstudie:
Insmed Completes External Assessment of Myotonic Muscular Dystrophy Market Study Estimates Potential Myotonic Muscular Dystrophy Market Could be as High as $800 Million to $1.4 Billion
http://investor.insmed.com/releasedetail.cfm?ReleaseID=28887…)


Studiendaten für MMD:

+++Start PII MMD (erster Teil), Januar 2006:+++
U. of Rochester Initiates Phase 2 Clinical Trial of Insmed's iPlex for the Treatment of Myotonic Muscular Dystrophy
http://investor.insmed.com/releasedetail.cfm?ReleaseID=18307…
growth rates & safety profile:
http://investor.insmed.com/releasedetail.cfm?ReleaseID=19475…
Studienergebnisse ENDO 2006:
http://investor.insmed.com/releasedetail.cfm?ReleaseID=20207…
promissing results, Mai 2007:
http://investor.insmed.com/releasedetail.cfm?ReleaseID=24057…

Die letzt News komplett, da sie sehr wichtig ist:

Insmed Announces Promising Results From IPLEX Phase II Myotonic Muscular Dystrophy Clinical Study, 2007

RICHMOND, Va., May 03, 2007 (BUSINESS WIRE) -- Insmed Inc. (Nasdaq:INSM) today announced positive results from a Phase II investigator-sponsored study of the company\'s drug, IPLEX(TM), in patients with myotonic muscular dystrophy (DM1).

Preliminary results of the clinical study, being conducted at the University of Rochester School of Medicine and Dentistry, showed that six months of treatment with doses of IPLEX up to 1 mg/kg/day in six patients met the primary study endpoints of being safe and well tolerated. In addition, IPLEX treatment was associated with improvements in muscle mass, cholesterol and triglycerides. During the six months of treatment, 5 out of 6 patients experienced an improvement in lean muscle mass. Patients also reported improvement in gastrointestinal function, endurance and cognitive function during treatment with IPLEX.

\"We are very encouraged by the results from this preliminary study of IPLEX in myotonic dystrophy. The results not only indicate IPLEX was safe, well tolerated and had a positive effect on muscle and lipid metabolism, they also suggest IPLEX may have a positive effect on aspects of the disease that affect patients\' daily living,\" said Dr. Geoffrey Allan, president and CEO of Insmed.

Study Description

The primary objectives of this ongoing open-label, Phase II dose escalation study are to examine the safety and tolerability of once-daily, subcutaneous injection of IPLEX in up to 15 patients with DM1 and to identify the maximum tolerated dose. The next cohort of patients will be treated for six months with a dose of IPLEX which will be titrated up to 2 mg/kg/day.

The study is funded by the National Institutes of Health and the Muscular Dystrophy Association, with supply of IPLEX drug provided by Insmed. A Phase II, placebo-controlled study to further investigate the safety and efficacy of IPLEX in a larger number of patients with DM1 is being designed based on the preliminary results of this study.

weiter gehts:

+++Start PII MMD (zweiter Teil), November 2007:+++

http://investor.insmed.com/releasedetail.cfm?ReleaseID=27312…
initiation phase II MMD, zweiter Teil

Die letzt News komplett, da sie sehr wichtig ist:

Insmed Announces Initiation of Phase II Clinical Trial with IPLEX(TM) in Myotonic Muscular Dystrophy
Promising Results Observed in Ongoing Open Label Trial

RICHMOND, Va., Nov 05, 2007 (BUSINESS WIRE) -- Insmed Inc. (Nasdaq:INSM), a biopharmaceutical company focused on the development and approval of drugs for the treatment of metabolic diseases with unmet medical needs, today announced the planned initiation of a 24-week, multi-center, randomized, double blind, placebo-controlled Phase II clinical trial with IPLEX(TM) in patients with Myotonic Muscular Dystrophy. The decision to initiate this trial is based on the promising results from an ongoing open-label, dose-escalation trial of IPLEX(TM) in this indication.

Up to 70% of the patients analyzed in an ongoing open-label, dose-escalation trial have reported improvement in one or more of several symptoms commonly associated with Myotonic Muscular Dystrophy, including cognitive function, gastrointestinal function, muscle pain, arm and leg strength, fatigue and endurance. Specific assessment of endurance demonstrated an improved performance in the six minute walk test, a well accepted FDA approval end point. Improvements in endurance were comparable to other drugs approved where this test was used for FDA approval. The six minute walk test is a well accepted, validated, quantitative measure of endurance and has been used as a primary endpoint in pivotal studies of several FDA approved drugs.

The purpose of the Phase II study is to confirm the positive results obtained in the open-label dose escalation trial in a multi-center, randomized, double-blind, placebo-controlled setting. The study will include 60 patients and will be powered to detect a 75 meter difference between IPLEX(TM) and placebo for the change in distance walked during the six minute walk test. The results from this Phase II study will be used to establish the design for Phase III clinical development.

Dr. Geoffrey Allan, Ph.D., Insmed's President and Chief Executive Officer, said, "We are very excited by our initial observations with IPLEX(TM) in the management of this major debilitating condition where there is no effective treatment and we are extremely pleased to announce the initiation of this expanded study. Provided the results of this confirmatory clinical trial replicate those of the ongoing, open-label, dose-escalation study, we believe we will be able to rapidly move IPLEX(TM) into Phase III development for Myotonic Muscular Dystrophy, an indication which we believe represents a significant market opportunity for the company."

weiter gehts:

orphan drug designation, Dezember 2007
http://investor.insmed.com/releasedetail.cfm?ReleaseID=28230…

Was sind orphan drugs?
http://biotech.about.com/od/faq/f/orphandrugs.htm

weiter gehts:

MMD Update, July 2008
http://investor.insmed.com/releasedetail.cfm?ReleaseID=32327…

Letztere News komplett, da sehr wichtig:

Insmed Provides Update on IPLEX(TM) Programs
-- MMD Phase 2 Trial Fully Enrolled --

RICHMOND, Va., July 21, 2008 /PRNewswire-FirstCall via COMTEX News Network/ -- Insmed Inc. (Nasdaq CM: INSM), a developer of follow-on biologics (FOBs) and biopharmaceuticals, today provided an update on the status of its IPLEX(TM) development program.

Insmed's Phase 2 trial of IPLEX(TM) in Myotonic Muscular Dystrophy (MMD), which was initiated in December 2007, has seen a strong patient and physician interest and is now fully enrolled. The trial is a six month, randomized, double-blind, placebo-controlled trial conducted at 13 research centers across the USA. The trial endpoints include the six-minute walk test, an FDA-accepted measure of endurance, and various conventional measures of muscle function, muscle strength, cognitive function, gastrointestinal function, general health, pain, insulin sensitivity, safety and tolerability. As previously announced, a substantial portion of the external costs associated with the study are expected to be covered by an approximately $2.1 million grant awarded to Insmed by the Muscular Dystrophy Association in late 2007. ...

Danke für die Aufmerksamkeit.

p.s. Einige bezeichnen IPLEX als Jungbrunnen mit mehreren Billionen Marktpotenzial (sales).


..to be continued, muss erstmal an die Sonne.

[orfmen]

Antwort auf Beitrag Nr.: 37.281.253 von [KERN]Codex am 29.05.09 13:33:09

VIELEN...VIELEN DANK!!! für deine Mühe!
Du wirst bald merken, es hat sich gelohnt!

Nu verstehe ich es auch!

Da scheinst du ja wirklich eine interssante Fährte zu wittern!
Ich muss da mal drüber schlafen, ach ne morgen is ja zu....und Montag jibts vielleicht nix mehr!

Ich kann mir doch nicht noch ein Ei ins Nest legen, wie soll ich denn das alles noch überblicken......

Grübel...Grübel!

Ich melde mich!

[orfmen]

Antwort auf Beitrag Nr.: 37.281.253 von [KERN]Codex am 29.05.09 13:33:09

...to be continued, muss erstmal an die Sonne

Verstehe zwar nur den Rest, aber muss auch noch was schaffen!

Ach so, wem diese schöne Zuammenfassung geholfen hat, der darf sich ruhig mal einloggen und Kerni für seine Mühe danken, denn soetwas dauert ein paar Stunden, auch für ihn!

Grüße!

[[KERN]Codex]

Naja eine Stunde hats gedauert, nicht so wild. War interessant zu recherchieren, aber ist noch nicht komplett.

[dyna6]

Antwort auf Beitrag Nr.: 37.281.772 von [KERN]Codex am 29.05.09 14:29:54

Auch von mir vielen Dank für Deine Arbeit

[[KERN]Codex]

Leider haben wir keine Asco Präsentation, aber dafür einige News für die kommenden Wochen in der Pipeline, besonders die Phase IIb MMD Daten, das mögliche ISPEN opt-in, die ROP Studie, Phase 3 Announcement MMD. Wenn alle Endpunkte erreicht werden gehts sehr schnell Richtung meines anvisierten Kursziels von 4-5 USD.

[[KERN]Codex]

Total issued and outstanding shares of Insmed Incorporated Common Stock was 126,888,163.

[orfmen]

Hallo kerni,
kann Insmed in naher Zukunft mit Meilensteinzahlungen oder ähnliches rechnen.
Wann (schätzt du) kann hier mit regelmäßigem "Einkommen" gerechnet werde, best case?
Wie hoch können peaksales nach zweitem Jahr geschätzt werden.
Nur rein aus deinem Bauch geschätzt, nix mit Quelle. Ich nagele dich nicht daran fest.
Sorry, muss mich erst einarbeiten und mache es mir einfach und frage schnell mal den Experten von Insmed!

Grüße!

[DaenischeSuedsee]

. . . . a.k.

[orfmen]

Hui, ich bin ja schon 10 cent über Wasser, geil!
Sonst fallen die Aktien immer erst eine Weile, nachdem ich eingestiegen bin.

Kerni,
ich hab ein gutes Gefühl bei der Sache!

[[KERN]Codex]

Es kommt drauf an,

Ipsen opt.in Ja/Nein,

wenn ja gibts nochmal 20 Mio. Cash Infusion (geschätzt)

wenn iplex für "short stature" zusammen mit ipsen vermarktet wird

dann sales 2010 500 mln short stature

ab 2011 nochmal 500 mln drauf für mmd

alles ausbaufähig..

insm sollte 2010 eine mk von 2 - 3 bn haben

gruß

[orfmen]

Antwort auf Beitrag Nr.: 37.324.672 von [KERN]Codex am 04.06.09 23:05:14

2010 das ist doch nächstes Jahr, oder???

[[KERN]Codex]

Antwort auf Beitrag Nr.: 37.324.714 von orfmen am 04.06.09 23:10:50

denk dran ich bin von natur aus ein positiv eingestellter mensch und heute wegen heb sehr euphorisch bin weg..

[DaenischeSuedsee]

!

Dieser Beitrag wurde moderiert. Grund: themenfremder Inhalt

[orfmen]

Schade, dass ich so wenig Zeit habe!
Insmed scheint wirklich ein kleiner Schatz zu sein.
Interessante Indikation, könnte enorm ausbaufähig sein.
Schon 25 cent über Wasser, das ist ein gutes Omen für mich!
Grüße!

[orfmen]

Antwort auf Beitrag Nr.: 37.332.527 von orfmen am 05.06.09 19:58:15

Ach so noch vergessen, lest Euch durch was kerni zusammengetragen hat und lasst die Phanta spielen, hier schlummert was Großes!!!

[Indium]

Antwort auf Beitrag Nr.: 37.332.539 von orfmen am 05.06.09 19:59:58

@orfman,
bin schon seit Okt 2007 dabei. Für mich sieht die "Über-Wasser-Rechnung" so aus:
1$ -> +20%
2$ -> +135%
5$ -> +500%
20$ -> +2300%

@[KERN]Codex,
2,5 bln mk / 125 mio shares = 20$ pro share und die halte ich auch für möglich!

[orfmen]

Antwort auf Beitrag Nr.: 37.334.391 von Indium am 06.06.09 07:56:23

Ich würde mich für dich freuen, wenn die 20$ fällt.
Noch mehr würde ich mich freuen, wenn du es so lange aushalten kannst.
Ab einer bestimmten Marke, fällt es immer schwerer nicht den Verkaufsknopf zu drücken.
Am besten man schmeisst den Rechner ins Klo, verbrennt den TAN-Block und entsorgt alle Spuren die einem zum Broker führen könnten.

VIEL GLÜCK!!!

[[KERN]Codex]

Antwort auf Beitrag Nr.: 37.335.656 von orfmen am 06.06.09 14:52:34

Genau so ist das! Ich werde meine shares einfach liegen lassen, die P3 werde ich schon überstehen, auch wenn die 1 Jahr dauert. (?) Also im Sommer 2010 könnte sich der Kurs dann den besagten 1-2,5 bn annähern in positiver antizipation eines fda approvals gegen ende 2010 (orphan drug, fast track) (knapper Zeitplan oder?)

ABER worauf ich primär sezte sind erstmal bahnbrechende MMD Daten und darauffolgend eine Zusammenarbeit mit IPSEN, wenn die beiden Firmen sich entscheiden anstatt Increlex - Iplex für Short Stature zu vermarkten dann klingelt mit der SALES FORCE von Ipsen schon in diesem Jahr die Kasse. Increlex hat nämlich gerade mal 5 Mio Sales im Q1 2009 eingefahren, ich denke alle wissen das Iplex besser ist.

INSMED hat eine Burn Rate von jetzt 5 Mio. pro Jahr. 125 Cash. Dazu kommen weitere 25 Mio. bei einem Ipsen "opt in". Und dann auch noch xx Sales aus dem Iplex Verkauf, wenn anstatt Increlex - Iplex vermarktet werden würde.

Werden die MMD Daten überragend, werden wir in diesem Jahr, vielleicht schon bis Herbst Kurse um die 5 USD sehen.

Viel Spaß.

[[KERN]Codex]

Heute könnten wir die 2 USD knacken, es sind 2,7 Millionen Aktien short, das könnte uns ordentlich nach oben katalpultieren wenn die MMD Daten kommen.

Short Interest (Shares Short) 2,721,500
Days To Cover (Short Interest Ratio) 3.3
Short Percent of Float 2.25 %
Short Interest - Prior 2,438,000
Short % Increase / Decrease 11.63 %
Short Squeeze Ranking™ 16

[[KERN]Codex]

Bei meinem letzten Thread wo soo wenig loswar (VENTANA) ist die Aktie von 1,6 auf 4,6 gelaufen, innerhalb von ein paar Wochen. Leute kommt aus dem Keller in die Küche, hier gibts was zu futtern.

[[KERN]Codex]

[actr]

Biologieaktien sind eben schwieriger zu "handln"! Aber ich wünsche dir viel Glück und viel Schotter

[Gilhaney]

Antwort auf Beitrag Nr.: 37.345.505 von [KERN]Codex am 08.06.09 17:57:16

Hallo [KERN]Codex,

Hätt´ste da nich früher Bescheid sagen könn´n ?


Gruß
Gilhaney

[orfmen]

Antwort auf Beitrag Nr.: 37.345.733 von Gilhaney am 08.06.09 18:20:01

Wenn ich mich mal einmischen darf.
Bin seit letzter Woche zu 1,61 dabei und glaube hier geht noch viel mehr,
sonst würde ich ja schon wieder verkaufen müssen. Überlege aber eher noch mal nachzufassen.
Wie ich schon schrieb, lest Euch den netten kleinen "Überblick" von kerni durch und lasst die Phantasie spielen, hier könnte gerade was Großes entstehen.

@kerni,
Könnte für uns in jeglicher Hinsicht ein heisser Juni werden! Wie hieß dein Börsengott nochmal?
Kannst du mich mal kurz bei ihm vorstellen?
Grüße!

[[KERN]Codex]

Antwort auf Beitrag Nr.: 37.345.599 von actr am 08.06.09 18:06:43

@actr, danke als student kann ich den schotter gut gebrauchen, immerhin gilt es die welt zu erkunden

@gillhaney, alles um und bei 2 usd ist super, dann hast du nicht soo viel verpasst, versprochen(!) auch ich habe gestern zu 1,3x nochmal nachgekauft
@orfman, der heisst ZEUS und sein Dreizack entläd sich immer in Form von Geistesblitzen

@all, auf eine schöne runde hier!

[orfmen]

Antwort auf Beitrag Nr.: 37.346.030 von [KERN]Codex am 08.06.09 18:52:19

sein Dreizack entläd sich immer in Form von Geistesblitzen
Genau das, was ich schon immer gesucht habe!
Brauche ich unbedingt, noch diese Woche, am besten gleich!

Wie konntest du gestern zu 1,3 nachladen?? Außerbörslich in Deutschland in €uro? Ist dir der Sonntag nicht heilig?

Grüße!

[[KERN]Codex]

Antwort auf Beitrag Nr.: 37.346.110 von orfmen am 08.06.09 19:01:59

Ach mit Gestern meinte ich Freitag in FFM

Auszug aus dem yahoo board:

Trigger Event @ $2.20/share 6-Jun-09 08:47 am
The share action last Friday confirms my suspicions that there is a drive by the INSM Warrant Holders to push the INSM share price to $2.20 by June 12 (Russell 2000 Day).

At $2.20/share there is a triggering event for half of the approximately 10 million outstanding INSM warrants (exchangeable @ $1.20/share). Per the last Annual Report, INSM has the right to purchase those 5 million warrants (net cost $5 million) when the share price hits the triggering amount.

For LONGS: This is good news as the number of outstanding warrants is reduced and the interest due on those warrants ceases (net future savings of almost $1 million). The sooner, the better.

For SHORTS: They will be kicking themselves for shorting INSM at a lower price and increasing their virtual screaming via posts on this message board. I will laugh at them. The irony is that some shorts will need to cover their positions, thus helping the Warrant Holders achieve their objective. No pity.

For PENNEY FLIPPERS: They were caught flat foot on Friday. They will need to become DIME FLIPPERS, if they want to participate in trading next week. Momentum players will be involved in trading next week too; however, the resources and motivations that the Warrant Holders have will outgun these players.

Sing with me: Up, Up and Away on My Beautiful Baloon …

[jacci]

Antwort auf Beitrag Nr.: 37.346.110 von orfmen am 08.06.09 19:01:59

müssen wir noch bis 9.9.09 warten ????

In Würzburg spricht Richard Moxley......


http://www.idmc-7.com/index.html

[[KERN]Codex]

Lest euch mal alle den Grundstoff für die Thread Diskussion durch:

http://en.wikipedia.org/wiki/Clinical_trial

Ich habe INSMED mal angeschrieben und ein paar Fragen gestellt zur Phase III und zum Ipsen opt-in. Ich werde die Antwort hier reinstellen.

Gruß

[Indium]

Insmed Stock Rising on High Volume, But Still a Good Buy
by: VFC's Stock House June 08, 2009
http://www.etfresources.com/article/141947-insmed-stock-risi…

[[KERN]Codex]

Hier ist eine gute Präsentation zur ALS:
ALS = AMYOTROPHIC LATERAL SCLEROSIS



http://www.als.ca/_media/docs/Wendy%20Johnston%20Case%20Conu…

Iplex für die Behandlung von ALS (Kleinwüchsigkeit) wurde von der FDA bereits zugelassen!

Wegen des Patentstreits mit Tercia/ Ipsen (ähnliches Medikament: Increlex) wurde Iplex aber wieder vom Markt genommen.

Das könnte sich in den nächsten Wochen wieder ändern => UND ihr wisst wie ein Drug Approval auf Biotech Aktien wirkt!!.

Deswegen auch die ganze Fantasie: Insmed hatte sich entschieden Iplex für andere Krankheiten zu testen und hat mit MMD = MYOTONIC MUSCULAR DYSTROPHY bisher sehr gute Studienergebnisse erzielt.

=>Also wir haben hier doppelte Fantasie, auf der einen Seite die MMD Phase IIb Daten, und auf der anderen Seite das mögliche opt-in (Zusammenarbeit mit INSMED) von Ipsen (eine Folge der Beilegung des Patenstreits), das sozusagen wie ein erneutes "Drug Approval" wirkt, weil Iplex wieder auf den Markt kommen könnte.

INSMED und IPSEN könnten IPLEX sofort produzieren und vermarkten, es ist alles vorhanden wa dazu nötig ist (Herstellungsanlagen, sales Force usw.)

Ich glaube das scheinen viele garnicht zu begreifen.

[Indium]

Antwort auf Beitrag Nr.: 37.351.215 von [KERN]Codex am 09.06.09 12:04:06

langsam wird Zeit für die folgende Nachricht:

As part of this transaction, Merck assumed the lease of our Boulder, Colorado-based manufacturing facility and acquired ownership of all the equipment in the building. In addition, upon closing of the transaction, Merck offered positions to employees of the Boulder facility. We retain our Richmond, VA corporate office, which houses our Clinical, Regulatory, Finance, and Administrative functions, in support of the continuing IPLEX™ program. The transfer of the Boulder facility to Merck takes away our internal IPLEX™ production capability. We believe, however, that we have sufficient inventory of IPLEX™ to support our ongoing Amyotrophic Lateral Sclerosis Expanded Access Program (“ALS EAP”) in Italy through 2010 together with the IPLEX™ requirement for the clinical trial currently being planned with the FDA for ALS patients in the US. Any requirements for IPLEX™ beyond 2010 or any significant increase in demand beyond our current commitments either in the Myotonic Muscular Dystrophy (“MMD”) or ALS fields will require that we identify a Contract Manufacturing Organization (“CMO”) to produce the necessary IPLEX™ to meet the demand. We estimate that the tech transfer of our IPLEX™ production process could take 12 to 18 months once a CMO has been identified.

Quelle: FORM 10-K For the fiscal year ended: December 31, 2008

[[KERN]Codex]

Jo ice on the cake

[[KERN]Codex]

2,20 USD halten wir das fest!

Nicht das jemand später sagt der Thread kam zu spät.

[orfmen]

Antwort auf Beitrag Nr.: 37.353.815 von [KERN]Codex am 09.06.09 16:14:05

Nicht das jemand später sagt der Thread kam zu spät.
Also ein bisschen früher hätte er schon kommen können.
Wo war noch das Jahrestief???
Ist aber egal, man muss nicht bei jeder Party von Anfang an mitfeiern, erst zum Ende hin sind die Leute gut drauf.

Grüße!

[[KERN]Codex]

Genau die Party geht gerade erst los, ich bleibe dabei: billiger wirds nicht! Nachbörslich rauf auf 2,16 USD = ~1,54 EUR. Ich glaube hätte der Makler nicht immer so große Spreads gäbe es auch in Deutschland mehr Volumen.

[orfmen]

Antwort auf Beitrag Nr.: 37.361.168 von [KERN]Codex am 10.06.09 11:22:56

ich bleibe dabei: billiger wirds nicht!
Ich werde mich wohl daran gewöhnen müssen, denn auf einen regen Austausch mit dir möchte ich nicht verzichten!
Also,
Blick frei geradeaus und manchmal die Augen zu und auf die Lippen gebissen, ich werde es versuchen!

Für alle anderen,
Bleiben sie am Ball, möglicherweise hier wird Geschichte geschrieben!
Insmed hat gerade einen guten Lauf, Vorboten von guten News???
Mit dem Spread hast du recht, der "verschreckt" die Anleger, wer aber immer darauf "Rücksicht" nimmt, verpasst eventuell ein gute Gelegenheit.
Ich habe ja viel Phantasie.
Ein Gedanke, können diese speziellen Wachstumshormone von Insmed auch lokal eingesetzt werden? Wenn ja, dann würden sich weitere riesige Märkte für die Zukunft auftun. Ich sehe gerade vor mir, wie verschiedene Körperteile ins Unermessliche wachsen.

Danke, dass kerni diese Perle uns noch einmal so auf Deutsch erläutert hat. Die Klickzahlen haben seitdem auch schon deutlich zugenommen, vermutlich hat es auch damit zu tun.
Wer etwas beizutragen hat, vielleicht sogar jemand vom Fach oder mit Erfahrung, nur zu! Es sind alle herzlich eingeladen hier mitzuwirken.
Das ist hier ein Forum und es wird um so wertvoller für alle, je mehr sich beteiligen. Auch konstruktive Kritik und negative Kommentare können wertvoll und nützlich für ALLE sein.
Vergessen Sie nie, wir wollen alle nur unser Bestes, und davon möglichst viel! Also sollte auch jeder versuchen, seinen Beitrag zu leisten, nicht dass einer denkt, hier gibts was geschenkt!

Disclaimer: Bin befangen bis über beide Ohren!

Grüße!

[orfmen]

Antwort auf Beitrag Nr.: 37.362.392 von orfmen am 10.06.09 13:02:59

Schon erstaunlich, wie Insmed sich wieder vom Tagestief erholt hat.
Ich wollte mich eigentlich von dir (kerni) huldigen lassen, wegen der Aussage ...billiger wirds nicht..., aber diesen Punkt hast du aus meiner Sicht gemacht (bis jetzt).
Wegen der zeitweiligen Intradayverbilligung muss ich kein Recht haben.
Mir ist es viel lieber, wenn du Recht behältst!!!
Sorry keine Zeit für research, dieses Baby muss mit wenig Hilfe das Laufen lernen.
Möchte sich weiter niemand hier beteiligen???
Los meldet Euch!!!
Grüße!

[[KERN]Codex]

Nach meinen 2,20 ging der Kurs nochmal runter auf 1,98 USD, also Leute wer hat die Chance genutzt? Das ist hier keine Promotion sondern ich will ernsthafte Beiträge warum INSMED mit Iplex den Jungbrunnen in den Händen hält!?

[orfmen]

Antwort auf Beitrag Nr.: 37.372.586 von [KERN]Codex am 11.06.09 15:18:39

Es hat mal jemand zu mir gesagt, wenn du willst, dass etwas vernünftiges dabei herauskommt, musst du es selbst machen.

Scheinbar gibt es im deutschsprachigen Raum bis jetzt niemand, der es sich zutraut und die Mühe macht hier ernsthafte Kommentare abzugeben.

Gründe dafür können sein:
Keine Ahnung - wie bei mir
Keine Zeit - wie bei mir seit kurzem
Kein Geld für eine Investition - bin schon drin
Kein Interesse - wächst bei mir mit jedem Tag
Zu wenig investiert so dass sich die Mühe kaum lohnt - kommt darauf an

Du siehst ich würde gern, aber aus den ersten beiden Gründen kommt wahrscheinlich nichts gescheites dabei heraus.

Grüße!

[orfmen]

Das ist zwar hornalt, aber doch interessant:

10.01.2007 17:35
Italien trifft Abkommen mit Insmed - Aktie steigt 18%
Die Aktien von Insmed stiegen heute um 18% auf 1,22 Dollar. Die italienische Regierung hat Insmed gebeten das Medikament Iplex für Patienten mit der sogenannten Lou Gehring´s-Krankheit zur Verfügung zu stellen.....

[orfmen]

Sollte helfen:
http://www.dgm.org/dgm-forum/showthread.php?t=6782

[orfmen]

http://als.over-blog.de/

[orfmen]

http://www.ipsen-pharma.de/pages/Therapiefelder/Wachstumssto…

[orfmen]

http://www.medknowledge.de/neu/med/jahr/2008/I-2008-9-mecase…

[Indium]

Insmed CEO Resigns Due to Health Concerns

On Monday June 15, 2009, 4:45 pm EDT

http://finance.yahoo.com/news/Insmed-CEO-Resigns-Due-to-prne…

[Nurbs]

Aus dem Forum:


Company WILL BE SOLD IMHO!!! 15-Jun-09 07:35 pm
1) No CEO
2) Less than 20 employees
3) Former CEO has hubris, never wanted to sell

IMHO the company will be sold regardless of MMD data.

If data are good, GA has too much excessive pride to sell the company for $5 - $8 - highly likely

If data are bad, GA would look like a coward - highly unlikely

This is very bullish. If data are bad, INSM can still be sold for $2.00 a share (cash+NOLs+residual Iplex value). If data are good, we're looking at $8 a share (a price that makes me happy but isn't appealing to GA).

Downside = 20%
Upside = 400%

I wish you a speedy recovery GA.


-----------------------------------


Iplex is a FDA approved drug.

You want math? I've been investing since you've been playing with your tiny Peter.
$1.00 a share in cash
$0.50 a share in NOL's ($150mn tax affected at 35%)
$0.50 value of drug pipeline (assuming IPLEX MMD failure). Iplex is still promising for ROP, ALS, and oncology.
That's $2.00 a share.

If MMD data is good, we're looking at a $1bn drug in my conservative scenario. Iplex is already approved by the FDA. If Ipsen opts in, I think they will bring Iplex back to the market for short-stature so doctors can immediately prescribe it off-label to MMD and ALS victims. If we assume that MMD is a $800mn market at the low end and INSM will have a 50% share, we're looking at $1.2bn at the min within three years (50% * $800mn * 3x ultra-conservative transaction multiple).

$1.2bn + cash balance + NOL's + ROP = more than $8 a share in value.

Don't question my lack of knowledge. I know the numbers. I don't post BS. IMHO, the risk-return has never been better.

The scenario of failed MMD and a subsequent acquisition is off the table without GA. If data is bad, we'll be sold for at least $2 a share.

How bout them numbers Penny? How bout you support my work and offer what you think is a more realistic scenario?


-----------------------------------


Quelle:
http://messages.finance.yahoo.com/mb/INSM

[Indium]

Insmed
20 Beschäftigte
120 Mio $ cash
MK 270 $
Medikament gegen MMD, ALS, ... in der Testpahase

Wie geht's nun weiter:
1. eine Schlacht um Insmed beginnt ?
2. Insmed wird aus eigener Kraft wachsen ?
3. Insmed wird für'n Apfel und'n Ei verkauft, dabei sahnen die Häuptlinge ab ?

[[KERN]Codex]

Wenn die MMD Daten die Endpunkte erreichen, Ipsen mit Insmed zusammen Iplex für ALS vermarktet haben wir Ende des Jahres eine 10 USD+ Aktie. Aktuell 2,35 USD - Halten wir das fest!

[silent_trader]

Antwort auf Beitrag Nr.: 37.422.436 von [KERN]Codex am 18.06.09 20:39:36

Dein Wort in Gottes Gehörgang!

Wenns nicht so ist, darf ich dich haftbar machen?

[Indium]

2,40$ = 300% Plus
bis bald bei 500%

[[KERN]Codex]

Antwort auf Beitrag Nr.: 37.422.927 von Indium am 18.06.09 21:42:16

Cool man, weiter so

[[KERN]Codex]

Antwort auf Beitrag Nr.: 37.422.436 von [KERN]Codex am 18.06.09 20:39:36

ich meinte natürlich:
"wenn Ipsen zusammen mit Insmed Iplex gegen Kleinwüchsigkeit (=short stature) vermarktet,.." da hat sich ein Fehler eingebaut.

und hier ist noch ein link zu ALS:
http://www.iplexforals.com/sf.html

[Indium]

Antwort auf Beitrag Nr.: 37.423.357 von [KERN]Codex am 18.06.09 22:35:12

Hi [KERN]Codex,
inzwischen müsste auch in Deinem Depot ein dickes Plus hinter INSM stehen! Hast Du noch einen anderen heißen Kandidaten auf dem Einkaufszettel stehen? Ich warte auf ca. $0,50 bei Capstone Turbine Corporation.
Grüsse

[[KERN]Codex]

Antwort auf Beitrag Nr.: 37.424.261 von Indium am 19.06.09 08:33:36

Also HEB und INSM sind schon meine heissen Kandidaten, vielleicht noch AGEN, aber die hab ich nicht im Depot. Sind aber auch günstig. Gruß

[Indium]

The Best Stocks for the Next 4 Years
By Adam J. WiedermanJune 20, 2009 |

http://www.fool.com/investing/small-cap/2009/06/20/the-best-…

[[KERN]Codex]

LONG & STRONG

Insmed bei 2,30 USD

Lesson learned?

[Aliasdaniel]

ISNM trading halt, news pending.

Scheisse, wollte heute kaufen und nun das

[Aliasdaniel]

Antwort auf Beitrag Nr.: 37.466.113 von Aliasdaniel am 25.06.09 14:03:30

INSM natürlich und nicht ISNM

[Aliasdaniel]

Insmed to Evaluate Potential Initiation of Phase II Trial for IPLEX(TM) in MMD Patients with Severe Insulin Resistance -


RICHMOND, Va., June 25 /PRNewswire-FirstCall/ -- Insmed Inc. (Nasdaq: INSM - News), a biopharmaceutical company, today announced results from its exploratory U.S. Phase II clinical trial evaluating IPLEX(TM) (mecasermin rinfabate) in patients with myotonic muscular dystrophy ("MMD"). The randomized, double-blind, placebo-controlled Phase II trial conducted in 13 centers across the U.S. enrolled 69 patients with MMD, for a six-month period. As this was an exploratory trial, a primary endpoint was not pre-defined. The trial explored measures of endurance, using the six-minute walk test, muscle function and strength, cognitive function, gastrointestinal function, pain, quality of life, insulin sensitivity, lipid metabolism, and safety and tolerability of IPLEX(TM).

The results of the trial indicated that IPLEX(TM) did not exhibit a statistically significant improvement in the functional measure of endurance by the six-minute walk test, muscle function, muscle strength, or quality of life in any of the tests utilized in this study. Based on the limited number of subjects enrolled with significant impairments in cognitive function, gastrointestinal function or pain, Insmed was unable to reach any conclusions regarding the effects of IPLEX(TM) on these endpoints.

IPLEX(TM) did, however, demonstrate improvements in standard measures of insulin sensitivity and reductions in fasting glucose, fasting insulin, cholesterol and triglycerides, which is consistent with the expected metabolic profile of insulin-like growth factor. Administration of IPLEX(TM) also resulted in anabolic effects of increased body mass index and higher levels of testosterone. The drug was well tolerated in MMD subjects and demonstrated a safety profile consistent with previous studies of IPLEX(TM).

Based on the metabolic improvements observed in patients treated with IPLEX(TM) in this trial, and discussions with key opinion leaders, the Company intends to apply for a grant from the Muscular Dystrophy Association ("MDA") to facilitate an additional Phase II trial focused solely on a subset of MMD patients with severe insulin resistance who, based on the results of this trial, may be more likely to benefit from IPLEX(TM) treatment. Alternative methods of assessing muscle function will be considered for the proposed trial.

Dr. Melvin Sharoky, Insmed's Chairman, commented, "We are disappointed that this trial did not meet the majority of its functional endpoints. However, the statistically significant improvement in insulin sensitivity seen in this study suggests that an additional phase II study in MMD patients with severe insulin resistance may be warranted. We appreciate the MDA's financial support for the completed trial and look forward to the possibility of continuing to work with them."

Sharon Hesterlee, Senior Vice President and Executive Director of MDA Venture Philanthropy, said, "While the phase II clinical trial of IPLEX(TM) did not show efficacy in the overall MMD population in this trial, based on the data generated, we look forward to evaluating Insmed's grant application for a possible Phase II trial aimed at MMD patients with severe insulin resistance."

Dr. Sharoky continued, "IPLEX(TM) continues to demonstrate a strong safety profile and we believe it offers a potential treatment in multiple therapeutic areas, including Amyotrophic Lateral Sclerosis. Beyond IPLEX(TM), our current cash reserves of approximately $120 million provides us with a significant opportunity to continue growing our business through a variety of potential business development initiatives. We look forward to continuing to explore these possibilities with our strategic financial advisor, RBC Capital Markets."

About Myotonic Muscular Dystrophy

Myotonic muscular dystrophy is a genetic disorder resulting in a highly variable presentation of symptoms across multiple body systems. The most prevalent symptoms include progressive muscular weakness and myotonia, cardiac arrhythmias, cognitive defects, cataracts, as well as well as endocrine, sexual, gastrointestinal and reproductive disturbances. There is currently no cure for the disease, which affects approximately 37,000 individuals in the U.S., and no specific treatment has been discovered to satisfactorily reverse or ameliorate the common symptoms associated with the disease. For more information on MMD, please visit www.mda.org.

About Insmed

Insmed Inc. is a biopharmaceutical company with unique protein development experience and a proprietary protein platform aimed at niche markets with unmet medical needs. For more information, please visit http://www.insmed.com.

[Aliasdaniel]

hört sich ja nicht so gut an

[[KERN]Codex]

120 mln cash + tax carry forwards + als + rop studien, solange sie insmed nicht dichtmachen ist die firma mehr wert als 1,14 usd (aktueller kurs - halten wir das fest) ich denke 1 euro könnte drin sein, threaderöffnung war bei 1,22 euro, aber viele sind leider erst später dazugestoßen.

an die die sich verabschieden, sorry für den scheisstipp!

[Queensryche3]

Rebound???

in der letzten Minute wurden 10 Mio. Shares umgesetzt

daraufhin stieg sie auf 1,15$

ist eigentlich noch jemand dabei?

[silent_trader]

Antwort auf Beitrag Nr.: 37.478.236 von Queensryche3 am 26.06.09 22:55:58

Ja, leider. War nicht hier als die Nachricht kam
Werde wohl die Verluste realisieren, aussitzen bringt hier nichts denke ich.

[dw1z]

wie stehen denn die chancen auf einen rebound?
bin auch noch investiert und möchte ungern mit 50% im minus raus

[Indium]

@alle,
ich werde die Flinte noch nicht ins Korn werfen. Zwar kann man MMD fast vergessen, aber Insmed hat noch einiges in der Pipeline (s.u.). Bei 120 mio cash hat Insmed keine Geldsorgen. Und wenn ein BigPharma INSM übernehmen will, kriegt er die shares nicht unter 2$. (bin aktuell 50% im Plus ($1.15))

Iplex™
Insmed maintains a propriety protein platform, based on the FDA-approved IPLEX™, as a development candidate for the treatment of neuromuscular and metabolic disorders. Insmed's proprietary pipeline using the IPLEX™ protein platform includes a treatment for myotonic muscular dystrophy (MMD), which was given an orphan drug designation by the FDA. In this indication, Insmed has completed a double-blind, placebo controlled phase II study. In addition, Insmed has an expanded access program for amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease, in Italy. And finally, Insmed has early stage research programs investigating retinopathy of prematurity (ROP) and HIV Adipose Redistribution Syndrome (HARS).

Oncology Programs
We have two oncology compounds, rhIGFBP-3 and INSM-18, in early development and both hold promise for the potential treatment for a variety of cancers. Preclinical models show that one or both treatments interact with the IGF-1 system to reduce tumor growth in models of breast, prostate, lung, colorectal and head and neck cancers. Although the oncology platform shows promise, the company's resources will be focused primarily on IPLEX™ and any further clinical trials in the oncology area are likely to be conducted either with a partner or potentially through out licensing.

[Indium]

An alterative view of the iPlex Study, some positive indications
Posted by Richard Weston on July 19, 2009 at 6:08am
View Richard Weston's blog
http://community.myotonicdystrophy.org/profiles/blogs/an-alt…

[Indium]

Insmed Provides Update on Supply of IPLEX(TM)
Company to Provide Remaining Supply of IPLEX(TM) to Ensure Continued Access Press Release
Source: Insmed Inc.
On Monday July 27, 2009, 8:00 am EDT

http://finance.yahoo.com/news/Insmed-Provides-Update-on-prne…

[jacci]

Antwort auf Beitrag Nr.: 37.652.392 von Indium am 27.07.09 14:48:35

schau mal an wie die aufgeladen haben:

http://www.mffais.com/insm

[Indium]

Antwort auf Beitrag Nr.: 37.740.636 von jacci am 09.08.09 18:55:55

... alles grün

am Donnerstag wird's interessant:
Insmed Incorporated Earnings Conference Call (Q2 2009)
Scheduled to start Thu, Aug 13, 2009, 8:30 am Eastern

[Indium]

INSMED’S (INSM) DRUG IPLEX™: VALUABLE, OR NOT VALUABLE?

VALUABLE, OR NOT VALUABLE?

After Insmed announced results from phase 2 clinical trial evaluating Iplex™ (mecaser-min rinfabate) on patients with myotonic muscular dystrophy ("MMD"), investors instigated a hysterical sell off of INSM on a very high volume. Capital is a coward, we know, especially in shaky economies, yet aggressive negative reaction to news based on fear only might not echo reality, which is much better sensed through an honest search for facts.
To begin with, investors should not have overlooked the fact that phase 2 clinical trial with Iplex on MMD was exploratory. The objective of this trial was to let researchers learn more about Iplex’™ as a therapeutic. The important polypeptide in Iplex is the insulin-like growth factor IGF-1, which scientists know now that in nature, it is involved, among other tasks, in children’s growth and in sustaining the muscle strength then after, i.e., it has an adult anabolic effect. It also has to do with glucose and lipid metabolisms. Researchers now recognize that using the free IGF-1 as therapeutic is limited by its toxicity at effective doses. That’s why the combination in Iplex of IGF-1 with its predominant binding protein IGFBP-3 has demonstrated much better results than using the free growth factor in short stature children and had promising results in other neurological diseases where other products failed.

Myotonic muscular dystrophy ("MMD") has complex symptoms, which comprise progressive muscular weakness and myotonia, cardiac arrhythmias, cognitive defects, endocrine disturbances including insulin sensitivity, testosterone imbalance, as well as deregulated lipid metabolism, gastrointestinal and reproductive deregulations and pain.

No rational professional analyst should have expected full accurate confirmatory results from a short-term exploratory trial with Iplex on a few patients suffering from MMD. That’s why the primary endpoint was not predefined. As a matter of fact, the trials were, yes, incapable of demonstrating positive effects of Iplex on the functional measure of endurance, muscle function and muscle strength, but were positive on other MMD complications. So, while investors reacted hysterically against the stock because of the negative side of the results, they totally overlooked the positive results of the drug on other important MMD complications, including, improvement in standard measures of insulin sensitivity - reductions in fasting glucose, fasting insulin, and on cholesterol and triglyceride high levels. They also closed their eyes on the results demonstrating that the use of Iplex rhas esulted in increasing body mass index and testosterone level.

These positive results confirm that Iplex has the same effect as the natural body insulin-like growth factor (IGF-1) without toxicity, thus, it can be used in diseases where the natural IGF-1 is deficient, or not sufficiently protective. Needless to repeat that the combination of IGF-1 with its binding protein IGFBP-3 enables administering the drug safely at higher therapeutic doses with no side effects as those produced through the use of free IGF-1 developed by other firms.

The data from phase 2 trial also tell scientists that if they wanted to reproduce the same effects as that of the natural IGF-1 in the body, the only current available drug for them is Iplex. We have no doubt that researchers at Insmed and at other firms interested in providing a therapeutic IGF-1 will do their best in finding effective Iplex combinations for debilitating neuromuscular, neurological and other diseases that have yet to find specific effective treatments.

Insmed is designing a new phase 2 trial that focuses solely on those patients who suffer from severe insulin resistance and are expected to benefit from the drug as seen from the unveiled results. Insmed intends to apply for a grant from the Muscular Dystrophy Association ("MDA"), which has largely supported the exploratory trials. The firm has considered using alternative methods that can demonstrate the effect of Iplex on muscle function.

Why do we need a therapeutic IGF-1?

The discovery of cytokines and growth factors and the developed of state-of-the-art tools for gene expression analysis have dramatically changed the understanding of many diseases. They handed scientists new tools that help them use natural body growth factors as therapeutics - a task that has been difficult to achieve.

Insulin-like growth factor 1, (IGF-1), for example, which was once called somatomedin C, and is part of Insmed’s complex drug Iplex™ is a polypeptide similar in molecular structure to insulin. IGF-1. It plays an important role in childhood growth and continues to have ananbolic effects in adults. IGF-1 activates the AKT signaling pathway, stimulates cell growth and multiplication and inhibits programmed cell death. It affects every cell in the human body, especially muscle cells, nerve cells, cartilage cells, bone, liver, kidney, skin and lung cells. IGF-1 and promises regulating cell nerve cell growth and development.

No wonder then why scientists dream of using this polypetide as therapeutic for growth related issues, for neuromuscular diseases and for metabolic diseases, especially diabetes.

Why Iplex?

Developing Iplex™ as a complex of recombinant human insulin-like growth factor-I (rhIGF-I) and IGFBP-3 (rhIGFBP-3) was a genius approach by Insmed. The complex solved the problem of dose restriction, enabled the drug to cross the blood brain barrier, increased its half life and freed it from the side effects that the free IGF-1 (Increlex and Myotrophin) – drugs developed by other firms. Iplex is given once a day, while free IGF-1 must be administered twice a day in a much lower dose.

Iplex™ was approved in the United States in December 2005 for the treatment of children with growth failure due to severe primary IGF-I deficiency. The advantages of this drug, however, convinced scientists’ that Iplex™ could be the drug the would play major roles in the treatment of serious neuromuscular diseases such as amyotrophic lateral sclerosis (ALS), myotonic muscular dystrophy (MMD), type 1 and type 2 dia-betes, retinal diseases, such as retinopathy of prematurity (ROP) and HIV adipose redistribution syndrome (HARS).

Amyotrophic lateral sclerosis (ALS): Insmed is currently providing Iplex in Italy through Expanded Access Program to physicians for ALS patients with promising re-sults. No other drugs, including free recombinant insulin-like growth factor-I (rhIGF-I), succeeded in inducing any improvement on the symptoms of this deadly disease. Many physicians are now putting their patients on Iplex™ in Italy. When the FDA heard the news about the Italian experience, it gave physicians the green light to use Iplex™ on compassionate basis on ALS patients in the U.S.

HIV adipose redistribution syndrome (HARS): Preliminary results from a phase 2 study conducted at the University of California, San Francisco on HIV patients suffering from HIV-associated adipose redistribution syndrome (HARS) showed that treatment with Iplex 0.5 mg/kg/day for three months only resulted in increasing IGF-I levels 3-fold. The administration of Iplex seems to be associated with significant improvements in fasting glucose levels, in the amount of insulin secreted during oral glucose tolerance test, and overall insulin sensitivity. Additionally, there was a significant reduction in patients’ trunk fat and lipid profiles.

If such a low dose of Iplex increased IGF-I levels 3-fold and positively impacted abnor-mal glucose metabolism, dyslipdemia and abnormal fat distribution, it is then fair to assume that a higher dose would have a better impact on improving glucose homeostasis. Competitors’ products have failedl to alter glucose homeostasis. It is important to note that abnormal glucose metabolism and dyslipedemia are present in a significant number of HIV patients treated with highly active antiretroviral therapy.

Retinopathy of prematurity (ROP)

Premacure is developing iplex™ as a potential treatment for Retinopathy of Prematurity (ROP) via a Material Transfer Agreement with Insmed. It seems that IGF-1 predominant binding protein IGFBP-3 (rhIGFBP-3), increased serum IGF-I levels into the normal range in significantly premature infants. These most recent study results were re-ported at the European Society for Pediatric Endocrinology 47th annual meeting, Istan-bul, Turkey, by Investigators from the Harvard Medical School, Boston MA, and the University of Gothenburg, The Karolinska Institute, Stockholm and Lund University, Sweden in a poster entitled "Pharmacokinetic study of recombinant human (rh) insulin-like growth factor/rh IGFBP-3 complex administered to very low birth weight infants.


Commenting on the Results

Lois Smith, Professor of Ophthalmology, Harvard Medical School, Children's Hospital Boston said, "The possibility of preventing ROP and other complications of prematurity by replicating the in utero environment after infants are born prematurely and lose the factors normally provided by the maternal environment is very exciting. This work shows that it is now possible to raise the serum level of IGF-1 and IGFBP-3 to normal in utero levels in these fragile infants with IGF-1/IGFBP-3 deficiency, which is a critical step in the development of interventions that prevent ROP. Since we have shown that low IGF-1 is associated with ROP, this offers the first possible intervention to prevent this blinding disease."

Ann Hellstrom, Professor in Pediatric Ophthalmology, Sahlgrenska Academy, Gothen-burg, Sweden said, "Our research focuses on promoting neural, vascular and metabolic development in premature infants. While in this study we are attempting to identify the benefits of IGF-I for ROP, our findings are also likely to be applicable to many aspects of complications of premature birth and could provide benefits for a lifespan."

Prevention of ROP

Low levels of IGF-I are known to contribute to the occurence of ROP. The objectives of the investigator-sponsored clinical study were to determine whether intravenous admini-stration of rhIGFI/rhIGFBP-3 (IPLEX™ could increase serum levels of these proteins in at-risk infants to levels seen in normal infants, and to evaluate the drug's safety and tol-erability. Due to consistency in response, the study was finalized after five infants. Treatment with IPLEX™ took place on the infant's chronological age day 3 and the investigators reported that the protein complex effectively raised serum IGF-I levels into the physiological range and that the drug's administration was well tolerated, with no acute adverse events.

With a drug like Iplex™ one cannot be pessimistic by results from trials that are not meant to prove but teach. We do believe that Iplex™ will, indeed, play a role in the treatment of many diseases, alone, or in combination treatments and as adjuvant to other treatments.

Insmed has agreements with Pharmacia AB’s portfolio of regulatory filings pertaining to rhIGF; and an agreement with NAPO Pharmaceuticals that gives NAPO the right to develop, manufacture, and commercialize masoprocal products for various indications relating to diabetes, cardiac disease, vascular disease, metabolic disease, and syndrome X.

Insmed also engages in various oncology programs, including INSM-18, an orally available small molecule tyrosine kinase inhibitor that has demonstrated selective inhibition of IGF-1 and human epidermal growth factor receptor; and rhIGFBP-3, which is in early clinical development stage for breast, prostate, liver, ovarian, and colon cancers.

The firm has around $120 million in cash reserves and is looking forward to continuing to explore Iplex™ possibilities with its strategic financial advisor, RBC Capital Markets.

ROP is a disease of the eye that affects prematurely born babies. It is thought to be cau-sed by disorganised growth of retinal blood vessels, which may result in scarring and retinal detachment. ROP can be mild, but may lead to blindness in serious conditions. It is one of the most common causes of visual loss in childhood and can lead to lifelong vision impairment and blindness. As such, all preterm babies are at risk for ROP, and very low birth weight is an additional risk factor.

Premacure AB, based in Sweden is dedicated to the development of diagnosis and prevention of complications in neonates due to premature birth. The first of several indications to be developed is Retinopathy of Prematurity (ROP).

What do you think? Do we hope that Iplex succeeds as therapeutic, because we need a safe and effective IGF-1 drug?

FORWARD-LOOKING STATEMENT: Prohost is independent publication providing information on biotech companies. Prohost does not accept compensation from companies that are featured or profiled.It is strongly recommended that any purchase or sale decisions to any of the featured com-panies be discussed with a financial advisor or broker prior to completing any such purchase or sale decision. All statements or expressions are the opinion of Prohost and are not meant to be a solicita-tion or recommendation to buy, sell, or hold securities. Investing in embryonic companies, micro-capand growth securities is highly speculative and carries a high degree of risk. It is possible that an investor can lose all of his/her investment in this type of companies that are profiled. The information that Prohost relies on is either through the profiled company, news services, research reports, inter-views, or other outside sources that Prohost believes are reliable. Prohost makes no representations, warranties or guarantees as to the accuracy or completeness of the disclosure of the profiled compa-nies and accepts no responsibilities for inaccuracies or misleading content in any material supplied by those clients.There can be no assurance that future events relating to the profiled company will occur as anticipated.The information contained herein is provided as an information service on-ly.Past performance of featured companies does not guarantee the future success of any currently featured or profiled company. We encourage our readers to invest carefully and read the investor information provided by the Securities and Exchange Commission ("SEC")and/or the National As-sociation of Securities Dealers ("NASD")We strongly recommend that you read the SEC advisory to investors concerning Internet Stock Fraud, which can be found at: http://www.sec.gov/consumer/cyberfr.htm.

07/13/2009

http://www.prohostbiotech.com/news_details.php?news_id=515&P…

[Indium]

Insmed Announces Financial Results for Second Quarter and Six-Months Ended June 30, 2009
Press Release
Source: Insmed Inc.
On Thursday August 13, 2009, 7:00 am EDT

http://finance.yahoo.com/news/Insmed-Announces-Financial-prn…

...
"We remain focused on leveraging our strong balance sheet to grow our business and enhance shareholder value," said Dr. Melvin Sharoky, Insmed's Chairman. "The entire Board and management team, along with our strategic financial advisers, RBC Capital Markets, are working aggressively to identify the appropriate course of action, and we aim to complete our strategic review of alternatives as quickly as reasonably possible."
...

[silent_trader]

Antwort auf Beitrag Nr.: 37.773.197 von Indium am 13.08.09 14:58:20

Mit anderen Worten: Sie haben noch keinen Plan.....

[Indium]

Antwort auf Beitrag Nr.: 37.774.482 von silent_trader am 13.08.09 16:39:59

... noch keinen Plan, aber viel Geld und Zeit. Mal schauen, ob sie daraus das Beste machen.
Grüsse

[Indium]

EP1828225 - GEREINIGTE RHIGF-I/RHIGFBP-3-KOMPLEXE UND HERSTELLUNGSVERFAHREN DAFÜR
Status Erteilung des Patents vorgesehen
Anmelder, Insmed, Inc.
Prüfungsverfahren 24.09.2009 Ankündigung der Patenterteilung

https://register.epoline.org/espacenet/application?lng=de&nu…

[Indium]

Insmed To Host Third Quarter 2009 Conference Call
Press Release
Source: Insmed Inc.
On 8:00 am EDT, Thursday October 22, 2009
Companies:Insmed Incorporated
RICHMOND, Va., Oct. 22 /PRNewswire-FirstCall/ -- Insmed Inc. (Nasdaq: INSM - News), a biopharmaceutical company, today announced that it will host a conference call on Friday, November 6th, at 8:30 AM ET, to discuss its financial results for the third quarter 2009. Insmed intends to issue its quarterly financial results press release before the market opens on November 6th.

http://finance.yahoo.com/news/Insmed-To-Host-Third-Quarter-p…

[Indium]

INSMED’S (INSM) DRUG IPLEX™: VALUABLE, OR NOT VALUABLE?

VALUABLE, OR NOT VALUABLE?


After Insmed announced results from phase 2 clinical trial evaluating Iplex™ (mecaser-min rinfabate) on patients with myotonic muscular dystrophy ("MMD"), investors instigated a hysterical sell off of INSM on a very high volume. Capital is a coward, we know, especially in shaky economies, yet aggressive negative reaction to news based on fear only might not echo reality, which is much better sensed through an honest search for facts.
To begin with, investors should not have overlooked the fact that phase 2 clinical trial with Iplex on MMD was exploratory. The objective of this trial was to let researchers learn more about Iplex’™ as a therapeutic. The important polypeptide in Iplex is the insulin-like growth factor IGF-1, which scientists know now that in nature, it is involved, among other tasks, in children’s growth and in sustaining the muscle strength then after, i.e., it has an adult anabolic effect. It also has to do with glucose and lipid metabolisms. Researchers now recognize that using the free IGF-1 as therapeutic is limited by its toxicity at effective doses. That’s why the combination in Iplex of IGF-1 with its predominant binding protein IGFBP-3 has demonstrated much better results than using the free growth factor in short stature children and had promising results in other neurological diseases where other products failed.

Myotonic muscular dystrophy ("MMD") has complex symptoms, which comprise progressive muscular weakness and myotonia, cardiac arrhythmias, cognitive defects, endocrine disturbances including insulin sensitivity, testosterone imbalance, as well as deregulated lipid metabolism, gastrointestinal and reproductive deregulations and pain.

No rational professional analyst should have expected full accurate confirmatory results from a short-term exploratory trial with Iplex on a few patients suffering from MMD. That’s why the primary endpoint was not predefined. As a matter of fact, the trials were, yes, incapable of demonstrating positive effects of Iplex on the functional measure of endurance, muscle function and muscle strength, but were positive on other MMD complications. So, while investors reacted hysterically against the stock because of the negative side of the results, they totally overlooked the positive results of the drug on other important MMD complications, including, improvement in standard measures of insulin sensitivity - reductions in fasting glucose, fasting insulin, and on cholesterol and triglyceride high levels. They also closed their eyes on the results demonstrating that the use of Iplex rhas esulted in increasing body mass index and testosterone level.

These positive results confirm that Iplex has the same effect as the natural body insulin-like growth factor (IGF-1) without toxicity, thus, it can be used in diseases where the natural IGF-1 is deficient, or not sufficiently protective. Needless to repeat that the combination of IGF-1 with its binding protein IGFBP-3 enables administering the drug safely at higher therapeutic doses with no side effects as those produced through the use of free IGF-1 developed by other firms.

The data from phase 2 trial also tell scientists that if they wanted to reproduce the same effects as that of the natural IGF-1 in the body, the only current available drug for them is Iplex. We have no doubt that researchers at Insmed and at other firms interested in providing a therapeutic IGF-1 will do their best in finding effective Iplex combinations for debilitating neuromuscular, neurological and other diseases that have yet to find specific effective treatments.

Insmed is designing a new phase 2 trial that focuses solely on those patients who suffer from severe insulin resistance and are expected to benefit from the drug as seen from the unveiled results. Insmed intends to apply for a grant from the Muscular Dystrophy Association ("MDA"), which has largely supported the exploratory trials. The firm has considered using alternative methods that can demonstrate the effect of Iplex on muscle function.

Why do we need a therapeutic IGF-1?

The discovery of cytokines and growth factors and the developed of state-of-the-art tools for gene expression analysis have dramatically changed the understanding of many diseases. They handed scientists new tools that help them use natural body growth factors as therapeutics - a task that has been difficult to achieve.

Insulin-like growth factor 1, (IGF-1), for example, which was once called somatomedin C, and is part of Insmed’s complex drug Iplex™ is a polypeptide similar in molecular structure to insulin. IGF-1. It plays an important role in childhood growth and continues to have ananbolic effects in adults. IGF-1 activates the AKT signaling pathway, stimulates cell growth and multiplication and inhibits programmed cell death. It affects every cell in the human body, especially muscle cells, nerve cells, cartilage cells, bone, liver, kidney, skin and lung cells. IGF-1 and promises regulating cell nerve cell growth and development.

No wonder then why scientists dream of using this polypetide as therapeutic for growth related issues, for neuromuscular diseases and for metabolic diseases, especially diabetes.

Why Iplex?

Developing Iplex™ as a complex of recombinant human insulin-like growth factor-I (rhIGF-I) and IGFBP-3 (rhIGFBP-3) was a genius approach by Insmed. The complex solved the problem of dose restriction, enabled the drug to cross the blood brain barrier, increased its half life and freed it from the side effects that the free IGF-1 (Increlex and Myotrophin) – drugs developed by other firms. Iplex is given once a day, while free IGF-1 must be administered twice a day in a much lower dose.

Iplex™ was approved in the United States in December 2005 for the treatment of children with growth failure due to severe primary IGF-I deficiency. The advantages of this drug, however, convinced scientists’ that Iplex™ could be the drug the would play major roles in the treatment of serious neuromuscular diseases such as amyotrophic lateral sclerosis (ALS), myotonic muscular dystrophy (MMD), type 1 and type 2 dia-betes, retinal diseases, such as retinopathy of prematurity (ROP) and HIV adipose redistribution syndrome (HARS).

Amyotrophic lateral sclerosis (ALS): Insmed is currently providing Iplex in Italy through Expanded Access Program to physicians for ALS patients with promising re-sults. No other drugs, including free recombinant insulin-like growth factor-I (rhIGF-I), succeeded in inducing any improvement on the symptoms of this deadly disease. Many physicians are now putting their patients on Iplex™ in Italy. When the FDA heard the news about the Italian experience, it gave physicians the green light to use Iplex™ on compassionate basis on ALS patients in the U.S.

HIV adipose redistribution syndrome (HARS): Preliminary results from a phase 2 study conducted at the University of California, San Francisco on HIV patients suffering from HIV-associated adipose redistribution syndrome (HARS) showed that treatment with Iplex 0.5 mg/kg/day for three months only resulted in increasing IGF-I levels 3-fold. The administration of Iplex seems to be associated with significant improvements in fasting glucose levels, in the amount of insulin secreted during oral glucose tolerance test, and overall insulin sensitivity. Additionally, there was a significant reduction in patients’ trunk fat and lipid profiles.

If such a low dose of Iplex increased IGF-I levels 3-fold and positively impacted abnor-mal glucose metabolism, dyslipdemia and abnormal fat distribution, it is then fair to assume that a higher dose would have a better impact on improving glucose homeostasis. Competitors’ products have failedl to alter glucose homeostasis. It is important to note that abnormal glucose metabolism and dyslipedemia are present in a significant number of HIV patients treated with highly active antiretroviral therapy.

Retinopathy of prematurity (ROP)


Premacure is developing iplex™ as a potential treatment for Retinopathy of Prematurity (ROP) via a Material Transfer Agreement with Insmed. It seems that IGF-1 predominant binding protein IGFBP-3 (rhIGFBP-3), increased serum IGF-I levels into the normal range in significantly premature infants. These most recent study results were re-ported at the European Society for Pediatric Endocrinology 47th annual meeting, Istan-bul, Turkey, by Investigators from the Harvard Medical School, Boston MA, and the University of Gothenburg, The Karolinska Institute, Stockholm and Lund University, Sweden in a poster entitled "Pharmacokinetic study of recombinant human (rh) insulin-like growth factor/rh IGFBP-3 complex administered to very low birth weight infants.


Commenting on the Results

Lois Smith, Professor of Ophthalmology, Harvard Medical School, Children's Hospital Boston said, "The possibility of preventing ROP and other complications of prematurity by replicating the in utero environment after infants are born prematurely and lose the factors normally provided by the maternal environment is very exciting. This work shows that it is now possible to raise the serum level of IGF-1 and IGFBP-3 to normal in utero levels in these fragile infants with IGF-1/IGFBP-3 deficiency, which is a critical step in the development of interventions that prevent ROP. Since we have shown that low IGF-1 is associated with ROP, this offers the first possible intervention to prevent this blinding disease."

Ann Hellstrom, Professor in Pediatric Ophthalmology, Sahlgrenska Academy, Gothen-burg, Sweden said, "Our research focuses on promoting neural, vascular and metabolic development in premature infants. While in this study we are attempting to identify the benefits of IGF-I for ROP, our findings are also likely to be applicable to many aspects of complications of premature birth and could provide benefits for a lifespan."

Prevention of ROP

Low levels of IGF-I are known to contribute to the occurence of ROP. The objectives of the investigator-sponsored clinical study were to determine whether intravenous admini-stration of rhIGFI/rhIGFBP-3 (IPLEX™ could increase serum levels of these proteins in at-risk infants to levels seen in normal infants, and to evaluate the drug's safety and tol-erability. Due to consistency in response, the study was finalized after five infants. Treatment with IPLEX™ took place on the infant's chronological age day 3 and the investigators reported that the protein complex effectively raised serum IGF-I levels into the physiological range and that the drug's administration was well tolerated, with no acute adverse events.

With a drug like Iplex™ one cannot be pessimistic by results from trials that are not meant to prove but teach. We do believe that Iplex™ will, indeed, play a role in the treatment of many diseases, alone, or in combination treatments and as adjuvant to other treatments.

Insmed has agreements with Pharmacia AB’s portfolio of regulatory filings pertaining to rhIGF; and an agreement with NAPO Pharmaceuticals that gives NAPO the right to develop, manufacture, and commercialize masoprocal products for various indications relating to diabetes, cardiac disease, vascular disease, metabolic disease, and syndrome X.

Insmed also engages in various oncology programs, including INSM-18, an orally available small molecule tyrosine kinase inhibitor that has demonstrated selective inhibition of IGF-1 and human epidermal growth factor receptor; and rhIGFBP-3, which is in early clinical development stage for breast, prostate, liver, ovarian, and colon cancers.

The firm has around $120 million in cash reserves and is looking forward to continuing to explore Iplex™ possibilities with its strategic financial advisor, RBC Capital Markets.

ROP is a disease of the eye that affects prematurely born babies. It is thought to be cau-sed by disorganised growth of retinal blood vessels, which may result in scarring and retinal detachment. ROP can be mild, but may lead to blindness in serious conditions. It is one of the most common causes of visual loss in childhood and can lead to lifelong vision impairment and blindness. As such, all preterm babies are at risk for ROP, and very low birth weight is an additional risk factor.

Premacure AB, based in Sweden is dedicated to the development of diagnosis and prevention of complications in neonates due to premature birth. The first of several indications to be developed is Retinopathy of Prematurity (ROP).

What do you think? Do we hope that Iplex succeeds as therapeutic, because we need a safe and effective IGF-1 drug?

FORWARD-LOOKING STATEMENT: Prohost is independent publication providing information on biotech companies. Prohost does not accept compensation from companies that are featured or profiled.It is strongly recommended that any purchase or sale decisions to any of the featured com-panies be discussed with a financial advisor or broker prior to completing any such purchase or sale decision. All statements or expressions are the opinion of Prohost and are not meant to be a solicita-tion or recommendation to buy, sell, or hold securities. Investing in embryonic companies, micro-capand growth securities is highly speculative and carries a high degree of risk. It is possible that an investor can lose all of his/her investment in this type of companies that are profiled. The information that Prohost relies on is either through the profiled company, news services, research reports, inter-views, or other outside sources that Prohost believes are reliable. Prohost makes no representations, warranties or guarantees as to the accuracy or completeness of the disclosure of the profiled compa-nies and accepts no responsibilities for inaccuracies or misleading content in any material supplied by those clients.There can be no assurance that future events relating to the profiled company will occur as anticipated.The information contained herein is provided as an information service on-ly.Past performance of featured companies does not guarantee the future success of any currently featured or profiled company. We encourage our readers to invest carefully and read the investor information provided by the Securities and Exchange Commission ("SEC")and/or the National As-sociation of Securities Dealers ("NASD")We strongly recommend that you read the SEC advisory to investors concerning Internet Stock Fraud, which can be found at: http://www.sec.gov/consumer/cyberfr.htm.


07/13/2009

http://www.prohostbiotech.com/news_details.php?news_id=515&P…

[Indium]

Insmed Announces Financial Results for Third Quarter and Nine-Months Ended September 30, 2009

RICHMOND, Va., Nov 06, 2009 /PRNewswire-FirstCall via COMTEX News Network/ -- Insmed Inc. (Nasdaq: INSM), a biopharmaceutical company, today reported results for the third quarter and nine-months ended September 30, 2009.

http://investor.insmed.com/releasedetail.cfm?ReleaseID=42248…

[Indium]

Daniel J. Popeo: If FDA blocks meds, how will government health care work?
By: Daniel J. Popeo
Examiner Staff Writer
November 20, 2009

http://www.washingtonexaminer.com/opinion/columns/OpEd-Contr…

[Indium]

The Schloss Screen for 2010
ByTim Melvin, RealMoney.com Contributor , On Wednesday January 6, 2010, 3:35 pm EST

Within the set parameters, however, there are a few bargains worth mentioning. One of the more interesting, Insmed, just barely makes the market-cap cut. The development-stage biotech company is something I normally avoid. However, this company has a market cap of $101 million and cash on the books of $121 million, so it is interesting. It is still running some research projects, but sold its core business earlier last year, and has been reducing expenses. It burns around $1 million a quarter, so it will remain a net cash stock for five years, given the current cash position and burn rate. It isn't the type of stock to sink a large part of your net worth into, but I would suggest that owning a small position could earn a goof return going forward, with a very large margin of safety.


http://finance.yahoo.com/news/The-Schloss-Screen-for-tsmp-13…

[Indium]

2010 Negative EV Stocks

Ticker Market Cap Enterprise Value Price

HCII 50.6 -38.6 $7.80 

ATV 140.1 -1.5 $4.73 

ACTS 207.2 -0.016 $2.41 

CAPS 29.3 -10.5 $0.72 

CHCG 25.8 -2.5 $0.50 

CMM 62.7 -110.3 $2.63 

FMCN 2100 -209.1 $15.85 

FOLD 89.8 -1.1 $3.97 

GRVY 45.3 -12.7 $1.63 

IDT 75.6 -17.4 $4.85 

INSM 96.2 -18.7 $0.77 

MTE 967 -37.6 $3.07 

MYRX 123.2 -33.5 $5.03 

NCTY 202.3 -79.8 $7.22 

NINE 62.2 -30.1 $1.74 

PDII 68.5 -7.8 $4.82 

QXM 171.3 -44.3 $3.66 

SCMRD 593.8 -49.4 $20.91 

TRID 117 -27.7 $1.86 

FMCN, CMM, NCTY, SCMRD, MYRX look very cheap indeed.

I’ve put this exact list of stocks in an investment tracking portfolio so it will be interesting to see the performance of this group at the end of the year.

Disclosure: I own INSM, GRVY, PDII at the time of writing.


http://seekingalpha.com/article/180649-19-negative-enterpris…

[Indium]

Letztes Ereignis 29.01.2010
(Voraussichtliche) Erteilung
veröffentlicht am 03.03.2010 [2010/09]

https://register.epoline.org/espacenet/application?number=EP…

[Indium]

FINAL TRANSCRIPT
MRK.PA - Merck & Co., Inc. at JPMorgan Healthcare Conference
Event Date/Time: Jan. 12. 2010 / 6:30PM GMT

And as we announced the Merck BioVenture in the last year or so, we continue to do acquisitions with Insmed and relationships
with Insmed and Avecia for a biological standpoint to build our infrastructure and manufacturing capabilities. So I think this
will be an important part of our strategy. It's not put on the back burner as some have suggested that would take place.

http://phx.corporate-ir.net/External.File?item=UGFyZW50SUQ9M…

[Indium]

Insmed to Host Fourth Quarter and Full-Year 2009 Conference Call
Press Release Source: Insmed Incorporated On Wednesday March 3, 2010, 8:00 am

RICHMOND, Va., March 3 /PRNewswire-FirstCall/ -- Insmed Inc. (Nasdaq:INSM - News), a biopharmaceutical company, today announced that it will host a conference call on Monday, March 15th, at 8:30 AM ET, to discuss its financial results for the fourth quarter and year-end 2009. Insmed intends to issue its quarterly financial results press release before the market opens on March 15th.

http://finance.yahoo.com/news/Insmed-to-Host-Fourth-Quarter-…

[Indium]

INSMED - Druckaufbau entlädt sich
André Rain, Donnerstag, 11. März 2010, um 19:33

http://de.finance.yahoo.com/nachrichten/insmed-druckaufbau-e…

[Indium]

Insmed Announces Fourth Quarter and Full-Year 2009 Financial Results
Press Release Source: Insmed Incorporated On Monday March 15, 2010, 7:00 am

http://finance.yahoo.com/news/Insmed-Announces-Fourth-prnews…

[Indium]

Insmed to Host First Quarter 2010 Conference Call

Press Release Source: Insmed Inc. On Thursday April 22, 2010, 8:00 am
RICHMOND, Va., April 22 /PRNewswire-FirstCall/ -- Insmed Inc. (Nasdaq CM: INSM), a biopharmaceutical company, today announced that it will host a conference call on Thursday, May 6th, at 8:30 AM ET, to discuss its financial results for the first quarter 2010. Insmed intends to issue its quarterly financial results press release before the market opens on May 6th.

To participate in the live conference call, please dial 866-783-2145 (U.S. callers) or 857-350-1604 (international), and provide passcode 75374293. A live webcast of the call will also be available at http://phx.corporate-ir.net/playerlink.zhtml?c=122332&s=wm&e… Please allow extra time prior to the webcast to register, download and install any necessary audio software.

The webcast will be archived for 30 days, and a telephone replay of the call will be available for seven days, beginning at 12:30 PM ET on May 6th, at 888-286-8010 (U.S. callers) or 617-801-6888 (international), using passcode 34687143.

About Insmed

Insmed Inc. is a biopharmaceutical company with unique protein development experience and a proprietary protein platform aimed at niche markets with unmet medical needs. For more information, please visit http://www.insmed.com.

Forward-Looking Statements

This release contains forward-looking statements which are made pursuant to provisions of Section 21E of the Securities Exchange Act of 1934. Investors are cautioned that such statements in this release, including statements relating to business strategies, plans and objectives of management and our strategic review process, constitute forward-looking statements which involve risks and uncertainties that could cause actual results to differ materially from those anticipated by the forward-looking statements. The risks and uncertainties include, without limitation, we may be unsuccessful in identifying or reaching agreement with acquisition or merger candidates, our expenses may be higher than anticipated and other risks and challenges detailed in our filings with the U.S. Securities and Exchange Commission, including our Annual Report on Form 10-K for the year ended December 31, 2009. Readers are cautioned not to place undue reliance on any forward-looking statements which speak only as of the date of this release. We undertake no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances that occur after the date of this release or to reflect the occurrence of unanticipated events.

Investor Relations Contact:
Brian Ritchie – FD
212-850-5683
[e-mail]

http://finance.yahoo.com/news/Insmed-to-Host-First-Quarter-p…

[Indium]

Insmed Announces First Quarter 2010 Financial Results

Press Release Source: Insmed Inc. On Thursday May 6, 2010, 7:00 am

http://finance.yahoo.com/news/Insmed-Announces-First-prnews-…

[Indium]

Insmed Announces Financial Results for Second Quarter and Six-Months Ended June 30, 2010
http://investor.insmed.com/releasedetail.cfm?ReleaseID=49624…

[Indium]

Insmed to Host Third Quarter 2010 Conference Call
http://finance.yahoo.com/news/Insmed-to-Host-Third-Quarter-p…

[KillingJoke]

Antwort auf Beitrag Nr.: 37.773.197 von Indium am 13.08.09 14:58:20

Hallo Indium,

heute tut sich endlich was bei Insmed.
Den Aktionären wird ein Merger vor den Bug geknallt.

Ich weiß nicht ob das so gut ist, denn viele sind in dem INSM investiert, weil die Firma unter dem Buchwert gehandelt wird. Durch den Merger bekommt man zwar eine Pipeline (die ich mir noch nicht angesehen habe), verdoppelt aber auch die Aktienanzahl.

Gruss
KJ

[Indium]

Insmed Incorporated and Transave, Inc. Announce Business Combination
INSMED INCORPORATED AND TRANSAVE, INC. COMBINE TO CREATE A BIOPHARMACEUTICAL COMPANY WITH NEAR-TERM COMMERCIAL OPPORTUNITIES
COMPANY TO HOST CONFERENCE CALL AT 8:30 AM ET TODAY

http://finance.yahoo.com/news/Insmed-Incorporated-and-prnews…

[Indium]

Antwort auf Beitrag Nr.: 40.631.737 von KillingJoke am 02.12.10 14:28:08

@KillingJoke,
ich habe gehofft, dass die Schnarchbude an einen Großen verkauft wird. Naja, schauen wir mal.
Grüsse
Indium

[KillingJoke]

Antwort auf Beitrag Nr.: 40.631.869 von Indium am 02.12.10 14:41:49

Indium,
ja, (die neue) INSM könnte sich noch als Falle entpuppen.

Da hoffen die Aktionäre stetig auf jemand, der am bestehenden Produkt interessiert ist und der Firma Leben einhaucht. Dann würde der Kurs anspringen hoch auf den Cashbestand plus die Produktpämie.

Stattdessen funktioniert es umgekehrt.
Die unterbewertete Firma sucht sich ein Spielzeug, mit dem erstmal "sicher" Geld verbrannt wird.
"Sehr unsicher" ist hingegen (wie bei allen Biotechs), ob die Pipeline hält was sie verspricht.

INSM hatte eine MarketCap von 91 Mio USD.
Bilanz zweigt einen Buchwert von 124 Mio USD.
Durch den Deal werden erstmal 7,8 Mio Schulden von Transave übernommen.
Dann kostet auch die Abwicklung ordentlich, so dass gemäß heutiger Meldung 110 Mio USD übrigbleiben.
"we believe the strength of the combined company's balance sheet, which after fees, debt payoff and other current liabilities, is presently estimated to be approximately $110 million, provides Insmed with the appropriate leverage to continue advancing ARIKACE™ through to commercialization."
Transave Schulden plus Gebühren machen also 13 Mio USD aus.

INSM hält dann nur 53,3 % an der kombinierten Firma.
"After giving effect to the merger, former Transave stockholders have approximately a 46.7% equity interest in the combined company (on an as-converted, fully diluted basis), and Insmed Incorporated shareholders have a 53.3% interest on a fully diluted, as exercised, basis."

Da kann man sich schnell ausrechnen, wieviel INSM die Pipeline von Transave gekostet hat.


Grüsse,
KJ

[KillingJoke]

Antwort auf Beitrag Nr.: 40.633.748 von KillingJoke am 02.12.10 17:36:50

Kurs aktuell 0,62 USD (-12%).
Der Deal kommt, wie vor Eröffnung vermutet, also tatsächlich nicht besonders gut an.

[Indium]

Antwort auf Beitrag Nr.: 40.633.748 von KillingJoke am 02.12.10 17:36:50

@KillingJoke,
IPLEX ist wohl inzwischen ein totes Pferd und INSM-18 wird nie erwähnt. M.M. nach ist ARIKACE kein Spielzeug für INSM, sondern DA-SEIN-Berechtigung als Biotech-Firma.
Zwar ein sehr teuerer Kauf der Katze-im-Sack, aber so läuft's halt bei Biotechs.
Die nächsten Tage werden zeigen, wohin die Reise geht.

(Bin z.Z. 12% im Minus )

Grüsse
Indium

[KillingJoke]

Antwort auf Beitrag Nr.: 40.637.804 von Indium am 03.12.10 08:46:57

Hallo Indium,
ich bin nicht investiert.

Alles in Allem muss man sich, glaube ich, auf diesem Kursniveau momentan nicht allzuviel sorgen machen.
Ich unterstelle, das INSM Management hat hier tief geprüft.
Transave ist eine "Katze-im-Sack" für die Aktionäre, die sich nach der überraschenden Nachricht erstmal einen Überblick verschaffen müssen, z.B. hier:
http://www.transaveinc.com/
http://www.transaveinc.com/products.shtml
http://www.transaveinc.com/patients.shtml
http://transaveinc.com/NewsEvents.aspx?category=Articles&arc…

Ich habe mir noch keine Meinung über ARIKACE™ gebildet.
In jedem Fall ist der Kurs ist nach unten erstmal wieder durch den Cashbestand abgesichert.
Evtl. begeistern sich ja auch bald Aktionäre für das Transave-Programm.
Gefahr besteht hier beim Aussitzen in den nächsten 2 Jahren, da nun ordentlich Geld verbrannt wird.
Bleiben die Meinungen zum Erfolg von ARIKACE™ neutral, bedeutet dass einen langsamen aber stetigen Kursverlust.
Scheitert ARIKACE™, wäre in 2014 Totalverlust zu befüchten.

"Transave's lead product candidate, ARIKACE™ (liposomal amikacin for inhalation), is initially being developed for cystic fibrosis (CF) patients with Pseudomonas lung infections and lung infections due to non-TB Mycobacteria (NTM). The combined company intends to initiate phase 3 clinical trials for ARIKACE™ in both indications in parallel during the second half of 2011. The results of these trials are expected in the first half of 2013, and will be followed by regulatory filings in the U.S. and Europe for both indications, pending successful trial outcomes. Based on current assumptions, the combined company believes it will have sufficient cash to progress ARIKACE™ to commercialization in the U.S."
Vor Ende 2013 ist hier nichts entschieden.

Gut ist, dass Aktionäre beim Cash-Bestand erstmal keine Kapitalerhöhung zu befürchten haben.
Schlecht ist, dass Transave eine private gehaltenen Firma ist.

Wer sowas liesst, freut sich vielleicht über einen bekannten Namen:
"Transave was backed by multiple well-known biotechnology venture capital funds, including Quaker BioVentures, Fidelity Biosciences, Prospect Venture Partners, TVM Capital, Forbion Capital Partners, Bessemer Venture Partners, and Easton Hunt Capital Partners."
Ich bekomm bei soetwas eher Panik. Alle Transave Aktionäre haben bald die Möglichkeit, Anteile an der Börse in Cash umzuwandeln...
... und insbesondere "Venture Capital" Geldgeber werden vermutlich grundsätzlich nicht auf eine FDA-Zulassung warten wollen.

Gruss von
KJ

[Indium]

zum Nachlesen: http://investor.insmed.com/secfiling.cfm?filingid=1104506-10…

[Indium]

2011 INSMED JP Morgan Investor Presentation
January 10, 2011

http://www.insmed.com/pdf/pubs-pres/2011_INSMED_JP_Morgan_In…

[Indium]

RS: eine Neue für zehn Alte

Item 8.01. Other Events.
On December 16, 2010, the Company issued a press release announcing that it was notified by the NASDAQ Stock Market that the Company has been granted an additional 180-day compliance period, or until June 13, 2011, to regain compliance with the $1.00 per share minimum bid price rule for continued listing on the NASDAQ Capital Market, as set forth in NASDAQ Listing Rule 5550(a)(2). The Company had previously announced that on June 18, 2010, the Company received a letter from the Listing Qualifications Department of the NASDAQ Stock Market indicating that the Company is not in compliance with NASDAQ Marketplace Rule 5550(a)(2) because the closing bid price per share for the Company's common stock, par value $.01 per share (the "Common Stock"), had been below $1.00 per share for 30 consecutive business days.

To regain compliance with the minimum bid price rule, the closing bid price of the Company's Common Stock must remain at $1.00 per share or more for a minimum of ten consecutive business days. If the Company does not regain compliance with the minimum bid price rule by June 13, 2011, NASDAQ will likely provide the Company with written notification that its Common Stock will be delisted. At that time the Company would be permitted to appeal NASDAQ's determination to delist the Company's Common Stock to a NASDAQ Hearings Panel.

In connection with the Company's efforts to regain compliance with the minimum bid price rule under Rule 5550(a)(2), on January 12, 2011, the Board unanimously adopted resolutions approving a reverse stock split of the Company's Common Stock. The Board also unanimously resolved to call a special meeting of the shareholders of the Company to consider and vote on a proposal to amend the Articles of Incorporation of the Company, as amended, to effect a one for 10 reverse stock split of the issued and outstanding shares of our Common Stock.

In addition, on January 12, 2011, the Board unanimously adopted resolutions calling for a special meeting of the shareholders of the Company to vote on a proposal to approve the conversion of the Company's Series B Conditional Convertible Preferred Stock issued to the former holders of preferred stock of Transave in connection with the business combination between the Company and Transave which was completed on December 1, 2011.

http://biz.yahoo.com/e/110114/insm8-k.html

[Indium]

Insmed to Participate on Phase III and Beyond Panel at 2011 RBC Capital Markets Healthcare Conference

RICHMOND, Va., Feb. 24, 2011 /PRNewswire/ -- Insmed Incorporated (Nasdaq:INSM - News), a biopharmaceutical company, announced today that Timothy Whitten, President & CEO of Insmed, will participate on the Phase III and Beyond panel as part of the 2011 RBC Capital Markets Healthcare Conference, which will be held at the New York Palace Hotel in New York City, from Wednesday, March 2nd, through Thursday, March 3rd.

The panel will be held at 9:00 AM ET on Thursday, March 3rd, and there will be a live audio webcast available at http://www.wsw.com/webcast/rbc129/rbc129.panel7. The webcast will also be archived for 30 days.


http://finance.yahoo.com/news/Insmed-to-Participate-on-prnew…

[Indium]

Insmed Shareholders Approve Conversion of Series B Conditional Convertible Preferred Stock and Reverse Stock Split

http://finance.yahoo.com/news/Insmed-Shareholders-Approve-pr…

Form 8-K for INSMED INC
http://biz.yahoo.com/e/110301/insm8-k.html