Besser als FLAMEL: BioSANTE (nach Wechsel von der OTC zur AMEX) - 500 Beiträge pro Seite

[Neoe]

Mittlerweile auch in Berlin erhältlich (Ticker Berlin:BSF;AMEX:BPA), bisher aber kein Handel:

BioSANTE Pharma

Ähnlich der Technik von Flamel, hat BioSANTE ebenfalls ein DeliveryTechnology:



Standbein Nummer 1
Calcium Phosphate Nanoparticles (CAP)

BioSante`s CAP nanoparticles are vehicles for delivering drugs and vaccines and enhancing the effects of vaccines. The key component, calcium phosphate, is on the FDA`s GRAS (Generally Regarded as Safe) list. BioSante`s CAP nanoparticles also have successfully passed the first stage of toxicity studies for administration orally, into muscles, under the skin and into the lungs by inhalation.


1.Vaccine Adjuvants

Most vaccines require the use of adjuvants to generate adequate protective immunity to prevent or treat diseases. As a result, most vaccines are combined with an adjuvant that enhances the ability of an injected vaccine to stimulate an immune response and thus protect the recipient by preventing or treating diseases. Currently, there is only one FDA-approved adjuvant for human use available, aluminum hydroxide or alum.

BioSante`s vaccine adjuvant (BioVant™ when combined with vaccines has been shown in animal studies, to elicit a higher immune response than non-adjuvanted vaccines and an immune response of the same magnitude as alum-formulated vaccines, at up to 100 times lower concentration of adjuvant.

BioSante has conducted animal studies to demonstrate the safety and efficacy of BioVant™ using various viruses and bacteria including flu, genital herpes, HIV, Epstein Barr and TB. Animal studies demonstrate that CAP elicits positive immune response to vaccines using either DNA-based or traditional protein antigen formulations.



2.Protein Delivery (Insulin)

BioSante has developed what it believes to be formulations for the oral delivery (BioOral™ of proteins, for example, insulin. These oral formulations are in pre-clinical testing. BioSante also has developed what it believes to be improved formulations for delivering proteins, for example, insulin to the lungs (BioAir™, more efficiently and less expensively than traditional methods. Today, insulin is given by frequent, inconvenient and often painful injections. Recent human clinical research indicates insulin delivered into the lungs can achieve the same result as injections. Pre-clinical trials of both BioOral and BioAir indicate sustained delivery of insulin with sustained control of glucose levels. Similar formulations may be used for the delivery of other proteins, for example, human growth hormone orally or to the lungs.

BioSante has completed pre-clinical tests showing both BioOral™ and BioAir™ extended the hypoglycemic effect of insulin when administered orally, sucutaneously and into the lungs. Study result have been and continue to be presented at various medical meetings.



3.Milk Protein Isolation

BioSante Pharmaceuticals, Inc. has been recently issued a U.S. patent for the advanced method of selectively isolating biologically active therapeutic proteins from transgenic milk in a casein-free supernatant.

Obtaining commercially viable yields of recombinant target protein from the milk of transgenic livestock remains a challenging task since milk is a complex, multiphasic (fat, casein, micelles, whey) colloidal suspension. We believe our patented process effectively addresses these well-known challenges and offers significant efficiency and economy compared to the currently employed methods.

BioSante`s objective is to license this technology on a royalty basis to companies interested in the production of therapeutic proteins in the milk of transgenic animals.

Known Limitations of Current Methods of Extracting Therapeutic Proteins:

Expensive, labor intensive and produce relatively low yields
Complexity of milk composition; cream-whey proteins-casein micelles
Casein constitutes 70 to 80 percent of the total milk protein and are insoluble
Caseins naturally form clusters and trap therapeutic proteins inside
The Advantages of the BioSante Transgenic Protein Delivery Process:

Dissolves the casein clusters, freeing the therapeutic proteins
Removes casein from the therapeutic protein, while preserving its biological activity
Fewer steps in the process to produce casein-free protein mixture
Leaves high concentrations of protein in the remaining crystal-clear whey fraction
Can be easily scaled to large pharmaceutical operations


Zusammenarbeit auf dem CAP-Gebiet mit:

US Army

US Navy

Corixa (NasdaqNM:CRXA)

National Institute Of Health (NIH) (small businness grant)

... weitere bisher nicht öffentlich benannte Partner.




Standbein Nummer 2
Präparate im Bereich Hormontherapie


Hormone Therapy

BioSante is focused on developing a product pipeline of human hormone therapy products. Symptoms treated with hormone therapy in men include impotence, lack of sex drive, muscle weakness and osteoporosis, and in women, menopausal symptoms such as hot flashes, vaginal atrophy, decreased libido and osteoporosis. The market for hormone therapy products (testosterone, estrogen and progestogen products) is approximately $2.5 billion dollars in the U.S. alone.

BioSante’s hormone therapy products are gel formulations of testosterone, estradiol, and combinations of estradiol and testosterone and estradiol and progestogen, respectively. The gels are designed to be quickly absorbed through the skin after application on the arms, shoulders, abdomen or thighs, delivering the required hormone to the bloodstream evenly and in a non-invasive, painless manner.

Current methods for hormone delivery include injections, dermal (skin) patches and a gel for testosterone delivery and oral pills or tablets or dermal patches for estrogen delivery. Dermal patches were developed primarily to promote the therapeutic effects of testosterone therapy without the often painful side effects associated with testosterone injections. Dermal patches, however, have been associated with skin irritation. BioSante’s hormone therapy products are gels formulated to be applied once per day and to be absorbed into the skin without a trace of residue. The testosterone and estradiol products deliver bioidentical hormones similar to men’s and women’s natural hormones.

Hormone Therapy Gel Products:

Bio-T-Gel ™ (male testosterone gel)
Bio-E-Gel ™ (estradiol gel)
LibiGel ™ (female testosterone gel)
LibiGel-E/T™ (estradiol + testosterone gel)
Bio-E+P-Gel™ (estradiol + progestin gel)


BioSante is developing a robust portfolio of transdermal gel hormone therapy products to treat men and women.

BioSante also is developing its nanoparticulate-based platform technology (CAP) for novel vaccines, vaccine adjuvants, drug delivery systems and biomanufacturing.






Die aktualisierten wichtigsten Fakten:

1.Erstes Gel ist nun in der PhaseIII angelangt. Nochmal der Hinweis auf die FDA-Richtlinien: Lediglich 3-monatige PhaseIII-Tests nötig.

2.Vor Kurzem 10,8 Millionen Dollar Investition durch
institutionelle Anleger

3.Mittlerweile nicht mehr OTCBB-gelistet, sondern an der AMEX und in Berlin. (AMEX:BPA;Berlin:BSF)


Kurs: 3,35$
M.cap: ca. 50 Millionen$
Website:http://www.biosantepharma.com

[Neoe]

Hier zuerst die News 2003 und dann ein guter Research-Bericht aus dem alten Thread:


News:

Oct. 7, 2003 BioSante Pharmaceuticals Announces Initiation of Phase III Clinical Trial of Bio-E-Gel

Oct. 1 , 2003 BioSante Pharmaceuticals Commences Trading On the American Stock Exchange

Sep. 25, 2003 BioSante Pharmaceuticals Approved for Listing on the American Stock Exchange

Sep. 19, 2003 BioSante Pharmaceuticals to Present at Friedland Capital`s Biotech, Medical and Healthcare Conference

Sep. 17, 2003 BioSante Pharmaceuticals to Present at UBS Global Life Sciences Conference

Sep. 8, 2003 BioSante Pharmaceuticals Announces Receipt of NIH Grant for Oral Insulin

Aug. 19, 2003 BioSante Pharmaceuticals Reports Superior Results With CAP Vaccines

Aug. 6, 2003 BioSante Pharmaceuticals Raises $10.3 Million in Private Placement

June 4, 2003 BioSante Pharmaceuticals Announces Biodefense Research and Development Agreement with U.S. Army


May 7, 2003 BioSante Pharmaceuticals Announces Positive Phase II/III Clinical Trial Results in Menopausal Symptoms

Apr. 29, 2003 BioSante Pharmaceuticals Announces Publication of Inhaled Insulin Study

Apr. 22, 2003 BioSante Pharmaceuticals Announces 2002 Financial Results and Key Achievements

Apr. 1, 2003 BioSante Pharmaceuticals Presents Positive Results of Oral Insulin Study at IIR-USA Meeting

Mar. 3, 2003 BioSante Pharmaceuticals Completes Phase II/III Clinical Trial in Menopausal Symptoms

Jan. 30, 2003 BioSante Pharmaceuticals Announces Malaria Research and Development with U.S. Navy

Jan. 6 , 2003 BioSante Pharmaceuticals Announces License Agreement With Teva Pharmaceuticals USA, Inc.



Research-Bericht:

http://www.jmdutton.com/Research/BISP/Reports/BISP_Report_08…

[Neoe]

Ausserdem sollte es bald mal News im Zusammenhang mit Corixa geben, was eigentlich niemand auf der Rechnung hat.

Es gibt ein paar Infos, dass demnächst ein gemeinsamer Tuberkulose-Impfstoff in die klinische Erprobungsphase gebracht wird. Daran ist ausserdem GlaxoSmithKline beteiligt:


Product Detail
Corixa`s product candidate, being developed with GlaxoSmithKline, is a combination of a proprietary antigen with an adjuvant.
Mycobacterium tuberculosis (Mtb) infection causes more deaths than any other infectious disease in the world. Each year, according to the World Health Organization (WHO), approximately 8 million people worldwide become sick with tuberculosis. According to WHO statistics, an estimated 2 million die annually from the disease. The WHO estimates that between 2000 and 2020 nearly 1 billion people will be newly infected with Mtb, 150 million people will get sick and 36 million will die. According to the National Institute of Allergy and Infectious Diseases, an estimated 2 billion people are infected with Mtb, including approximately 15 million people in the U.S. Any of these people may develop active tuberculosis during the course of their lives. In addition, the Sequella Global Tuberculosis Foundation estimates that more than 50 million people worldwide may be infected with drug-resistant strains of tuberculosis. Our goal is to develop specific vaccines for both conventional and drug-resistant strains of Mtb.


Clinical Trials
Corixa expects to initiate a U.S. Phase I clinical trial in 2003.



Hintergrundinfo:

BioSante Pharmaceuticals Announces Positive Trial Results
for Tuberculosis Vaccine

LINCOLNSHIRE, Ill., May 15 (2002,Anm.) -- BioSante Pharmaceuticals, Inc. (OTC Bulletin Board: BTPH) today announced successful results of a pre-clinical trial demonstrating the effectiveness of its calcium phosphate nanoparticulate (CAP) vaccine adjuvant and delivery system (Bio- Vant(TM)) in a tuberculosis (TB) vaccine. The results were presented in Prague, Czech Republic, at the Immunopotentiators in Modern Medicine meeting.

In the reported study, a tuberculosis subunit vaccine was combined with Bio-Vant in a proprietary formulation developed by scientists at BioSante`s research center in Smyrna, Georgia, and immune response was tested in a mouse model. The studies were designed to test the effects of Bio-Vant on the immunogenicity elicited compared to aluminum hydroxide, or alum, the only vaccine adjuvant approved for human use in the United States, and to cholera toxin (CT), a potent mucosal adjuvant. The mice were dosed intraperitoneally (through the abdominal wall), intranasally or orally.

The Bio-Vant-TB vaccine induced an antibody (IgG) response comparable to that of the alum group with no significant inflammation or allergy (IgE) response after intraperitoneal immunization. This is a particularly important advantage over alum-based vaccines, which are known to cause inflammation and allergic reaction. The Bio-Vant-TB vaccine also boosted the induction of TB- specific IgG2a to a level similar to the alum-based vaccine after a live TB challenge, a reaction that is widely recognized as characteristic of a Th1 CD4 T-cell response, which controls the replication of intracellular TB pathogens. In addition, oral immunization with the Bio-Vant-TB vaccine induced mucosal IgA and IgG antibody responses that were similar to the CT group.

"Based on these results and those from previous pre-clinical studies, we believe the use of Bio-Vant will result in effective vaccines with a potentially better safety profile than alum and other vaccine adjuvants in development," said Stephen M. Simes, president and chief executive officer of BioSante. "The positive results achieved with oral administration of the Bio- Vant vaccine indicate the development of convenient oral vaccines may be possible. Such a vaccine would be especially important for use in people of younger and older age groups and in geographic locations where injectable vaccines are difficult to deliver and administer."

Simes noted that BioSante and potential vaccine partners are conducting additional pre-clinical studies of CAP in several other potential vaccines, and BioSante is continuing to pursue licenses with biotechnology and pharmaceutical companies for the further development of CAP in all areas. The company announced in November a license agreement with Corixa Corporation for the development of CAP as a vaccine adjuvant.

CAP calcium phosphate nanoparticles are microscopic particles of a natural compound found in teeth and bones. BioSante`s proprietary formulation is nontoxic and biodegradable, and offers a multitude of potential medical applications.



Weitere Impfungen können jederzeit in klinische Tests kommen, allerdings ist dies nicht so einfach abzuschätzen, da sich hier teilweise in den klinischen Erprobungen weit fortgeschrittene Impfungen hält, deren Anwendungsbereich erweitert werden soll.

[Falke28]

Gute Researcharbeit und nette Beiträge!

Gruß
Falke28

[greenhorn1998]

Hi zusammen!

Hier auch noch einmal der Hinweis auf morgen Nachmittag unserer Zeit, zumal auch auf der Homepage von Biosante der Hinweis zu finden ist.

BioSante Pharmaceuticals to Present at Rodman & Renshaw
Techvest Healthcare Conference

Lincolnshire, Illinois - (October 20, 2003) - BioSante Pharmaceuticals, Inc. (AMEX:BPA) announced today that Stephen M. Simes, president and chief executive officer, will give a presentation to investors on Wednesday, October 22, at 5:20 p.m. EST during the Rodman & Renshaw Techvest Healthcare Conference at the Boston Marriot Long Wharf Hotel.

Mr. Simes` presentation will include a discussion of the company`s recent initiation of a Phase III clinical trial of Bio-E-Gel™ (estradiol topical gel) for treatment of menopausal symptoms. The presentation will be webcast and can be accessed at

http://www.wallstreetwebcasting.com/webcast/rrshq/bpa/

The webcast will also be archived on BioSante`s Web site, www.biosantepharma.com, for up to two weeks following the conference.

About BioSante Pharmaceuticals, Inc.

BioSante is an emerging pharmaceutical company developing a pipeline of hormone therapy products to treat both men and women. BioSante is also developing its nanoparticulate-based platform technology (CAP) for novel vaccines, vaccine adjuvants and drug delivery systems. Additional information is available online at www.biosantepharma.com.

Bin sehr gespannt, was es Simes über die Phase III-Test von Bio-E-Gel berichten wird und welche anderen Überraschungen er eventuell für uns parat hat.

Naja, mal abwarten.

Gruß, greenhorn

[MONSIEURCB]

Hm...also über Berlin ist definitiv nix zu kriegen - hab eben via AMEX zugeschlagen, für 3,39....good luck to all!

[greenhorn1998]

Hallo zusammen!

Es geht los! Und zwar mächtig. Die Aktie ist nach folgender Meldung derzeit mit knapp 10 Prozent im Plus, unter - im Vergleich - extrem hohem Volumen!!!

BioSante Pharmaceuticals Presents Positive Interim Results Using LibiGel™ for Treatment of Female Sexual Dysfunction

Lincolnshire, Illinois - (October 21, 2003) - BioSante Pharmaceuticals, Inc. (Amex: BPA) announced today that a blinded interim analysis of an ongoing Phase II trial of LibiGel™ (topical testosterone gel) for the treatment of female sexual dysfunction (FSD) showed statistically significant results for the primary endpoints of the study, according to data presented at a meeting of the International Society for the Study of Women`s Sexual Health (ISSWSH) in Amsterdam.

In the U.S.-based, double-blind, placebo-controlled study to determine the effect of LibiGel on women`s sexual activity and desire, after three months of treatment there was a 130 percent increase from baseline (p<0.01) in the frequency of satisfying sexual events as measured by individual patient diaries. In addition, there was a 136 percent increase from baseline (p<0.01) in sexual desire as measured by the Brief Index of Sexual Functioning for Women (BISF-W).

The interim analysis reports on the first 28 patients who have completed the study, without breaking the blind as to dose of LibiGel or placebo. The data indicate an effective LibiGel dose for the treatment of hypoactive sexual desire disorder (HSDD) in women, and that LibiGel was well tolerated during the course of the trial.

BioSante previously has completed three Phase I/II LibiGel clinical trials to determine blood levels of testosterone delivered by six different doses of LibiGel, which is administered as a topical gel. Data from these studies also were presented at the ISSWSH meeting and showed that LibiGel provides testosterone levels that are expected to be effective in treating HSDD.

"The data presented at the ISSWSH meeting in Amsterdam indicate that on a blinded basis, LibiGel improves sexual activity and desire in women suffering from hypoactive sexual desire disorder," said Stephen M. Simes, president and chief executive officer of BioSante. "We believe that LibiGel can make an important contribution to the well-being of women. Female sexual dysfunction is underserved by the pharmaceutical industry today, and we are very pleased LibiGel may help successfully address this unmet medical need."

LibiGel is a gel formulation of bioidentical testosterone designed to be quickly absorbed through the skin after application on the arms, shoulders or abdomen, delivering testosterone to the bloodstream evenly over time and in a non-invasive and painless manner. Though generally characterized as a male hormone, testosterone also is present in women and its deficiency has been found to decrease libido or sex drive. Studies have shown that testosterone therapy can increase bone density, raise energy levels, improve mood and boost sexual desire and pleasure.

According to a study published in the Journal of the American Medical Association, 43 percent of American women (about 40 million) experience some degree of impaired sexual function. Among the more than 1,400 women surveyed, 32 percent lacked interest in sex and 26 percent could not experience orgasm. The majority of women with FSD are postmenopausal, experiencing FSD due to hormonal changes following menopause, whether natural or surgical. BioInnovators, Inc., a pharmaceutical industry consulting group, estimates that within five years the U.S. market for testosterone products for women will exceed $600 million.

BioSante`s hormone therapy portfolio

In addition to LibiGel, BioSante is developing Bio-E- Gel™ (bioidentical estradiol gel) for the treatment of menopausal symptoms in women. Menopausal symptoms include hot flushes and vaginal atrophy. BioSante recently initiated a pivotal Phase III clinical trial of Bio-E-Gel to reduce both hot flushes and vaginal atrophy. Also in development is Bio-T-Gel? bio- identical testosterone gel for treatment of men with testosterone deficiency. Symptoms of these hormone deficiencies include impotence, diminished sex drive, muscle weakness and osteoporosis.

Additionally, a combination hormone therapy gel product containing estradiol and progestin is being developed under a license with Solvay Pharmaceuticals, B.V., and an unnamed BioSante hormone therapy product is being developed by Teva Pharmaceuticals USA, Inc. under a license agreement. In both agreements, the respective licensees are responsible for development, regulatory filings, manufacturing and marketing associated with their respective products. Also under both agreements BioSante has received upfront payments and will receive milestone payments and royalties when and if the products are approved and marketed.

The estrogen and testosterone markets in the United States alone account for approximately $3 billion in annual sales.

About BioSante Pharmaceuticals, Inc.

BioSante is an emerging pharmaceutical company developing a pipeline of hormone therapy products to treat both men and women. BioSante also is developing its nanoparticulate-based platform technology (CAP) for novel vaccines, vaccine adjuvants and drug delivery systems. Additional information is available online at www.biosantepharma.com.


Morgen die Konferenz!!! Es sieht gut aus!!!

Gruß, greenhorn

[poponase]

Na wir wollen mal hoffen dass edie Kurse nicht wieder abbröckeln und stetig steigen

[Neoe]

Interview des WallstreetTranscript mit CEO Simes:

http://www.biosantepharma.com/pub/TWST interview.pdf


Muss gleich noch eine Entschuldigung hinterherschicken. Leider geht das mit der PhaseIII doch nicht so schnell. Obwohl die Info, dass die Tests nur 3 Monate dauern von Biosante stammen, sagt Simes hier, dass es bis zum Abschluss der PhaseIII doch ca. 12 Monate benötigen wird, was mir völlig neu ist. Trotzdem sieht es alles in allem rosig aus.

[greenhorn1998]

Guten Abend!

Leider bröckeln die Kurse doch wieder ab, unter extrem geringen Volumen. Ich verstehe das nicht, aber gut.

Gruß, greenhorn, der diese Disskussion mal wieder nach oben heben wollte. Nachher rutscht die auch noch weiter ab.

[cristrader]

Vieleicht bewegt sich der Kurs bei dieser Meldung!

BioSante Pharmaceuticals Reports Positive Results of Long Acting Injectable Insulin
Thursday November 6, 11:01 am ET


SAN FRANCISCO--(BUSINESS WIRE)--Nov. 6, 2003--BioSante Pharmaceuticals, Inc. (Amex:BPA - News) announced today that positive results of preclinical testing of its calcium phosphate (CAP) delivery system for the injection of insulin were presented here at the third annual meeting of the Diabetes Technology Society.
"The results of this study indicate that our unique technology may extend the duration of action many times over that of injecting insulin alone," said Dr. Tulin Morcol, associate director of drug delivery and related technologies for BioSante. "This represents a potential advance that would allow diabetics to substantially reduce the number of injections needed to control blood glucose levels."

The preclinical study evaluated the use of BioSante`s proprietary CAP particles to extend the bioavailability of insulin over time. Scientists at BioSante`s research center in Smyrna, Georgia, developed a formulation combining CAP, polyethylene glycol (PEG, a polymer) and insulin. The therapeutic efficacy of the formulation, known as CAPI, was tested in normal and diabetic mice, and pharmacokinetic analysis was also performed.

A single 12.5 U/kg dose of CAPI was administered to fasted non-obese diabetic mice via subcutaneous injection and blood glucose and serum insulin levels were monitored for eight hours. Diabetic mice treated with a 12.5-U/kg dose of standard insulin solution were used as controls.

A single dose of CAPI at two dosage levels (2.5 U/kg and 5.0 U/kg) was also administered to fasted normal mice via subcutaneous injection, and normal mice treated with a 2.5-U/kg dose of standard insulin solution were used as controls. Blood glucose and serum insulin levels were monitored for seven hours.

In all cases, subcutaneously injected CAPI prolonged the absorption of insulin and substantially lowered blood glucose levels compared to insulin solution, the researchers reported, and the glucose lowering effect of CAPI was more dramatic in the diabetic mice model. CAPI extended the hypoglycemic effect of insulin to at least eight hours, compared to two to four hours for insulin alone.

"Pharmacokinetic analysis indicated that CAPI significantly increased the half-life and mean residence time of the insulin," Dr. Morcol said. "Furthermore, relative bioavailability of insulin in CAPI was 150 percent greater than insulin solution."

Dr. Morcol also pointed out that while there are long-acting diabetes therapies now on the market, they are made with analogs of insulin, whereas CAPI is formulated with human insulin, long the treatment of choice.

"The results of this study strengthen our belief that CAP is an important delivery technology for insulin treatment," said Stephen M. Simes, president and chief executive officer of BioSante. "This potential advance may substantially reduce the number of injections required by diabetics, thereby enhancing their quality of life."

Simes said the company plans to continue research on the new treatment as well as other delivery systems currently in development, including CAPOral(TM) for oral insulin delivery (for which the company recently received an SBIR grant) and CAPAir(TM) for inhalable insulin delivery.

CAP, BioSante`s proprietary calcium phosphate particulate technology, consists of microscopic particles of a natural compound similar to that found in teeth and bones. The patented formulation is nontoxic and biodegradable, offering a multitude of potential medical applications.

[cristrader]

Bewegt sich der Kurs bei dieser Meldung?

BioSante Pharmaceuticals Reports Positive Results of Long Acting Injectable Insulin
Thursday November 6, 11:01 am ET


SAN FRANCISCO--(BUSINESS WIRE)--Nov. 6, 2003--BioSante Pharmaceuticals, Inc. (Amex:BPA - News) announced today that positive results of preclinical testing of its calcium phosphate (CAP) delivery system for the injection of insulin were presented here at the third annual meeting of the Diabetes Technology Society.
"The results of this study indicate that our unique technology may extend the duration of action many times over that of injecting insulin alone," said Dr. Tulin Morcol, associate director of drug delivery and related technologies for BioSante. "This represents a potential advance that would allow diabetics to substantially reduce the number of injections needed to control blood glucose levels."

The preclinical study evaluated the use of BioSante`s proprietary CAP particles to extend the bioavailability of insulin over time. Scientists at BioSante`s research center in Smyrna, Georgia, developed a formulation combining CAP, polyethylene glycol (PEG, a polymer) and insulin. The therapeutic efficacy of the formulation, known as CAPI, was tested in normal and diabetic mice, and pharmacokinetic analysis was also performed.

A single 12.5 U/kg dose of CAPI was administered to fasted non-obese diabetic mice via subcutaneous injection and blood glucose and serum insulin levels were monitored for eight hours. Diabetic mice treated with a 12.5-U/kg dose of standard insulin solution were used as controls.

A single dose of CAPI at two dosage levels (2.5 U/kg and 5.0 U/kg) was also administered to fasted normal mice via subcutaneous injection, and normal mice treated with a 2.5-U/kg dose of standard insulin solution were used as controls. Blood glucose and serum insulin levels were monitored for seven hours.

In all cases, subcutaneously injected CAPI prolonged the absorption of insulin and substantially lowered blood glucose levels compared to insulin solution, the researchers reported, and the glucose lowering effect of CAPI was more dramatic in the diabetic mice model. CAPI extended the hypoglycemic effect of insulin to at least eight hours, compared to two to four hours for insulin alone.

"Pharmacokinetic analysis indicated that CAPI significantly increased the half-life and mean residence time of the insulin," Dr. Morcol said. "Furthermore, relative bioavailability of insulin in CAPI was 150 percent greater than insulin solution."

Dr. Morcol also pointed out that while there are long-acting diabetes therapies now on the market, they are made with analogs of insulin, whereas CAPI is formulated with human insulin, long the treatment of choice.

"The results of this study strengthen our belief that CAP is an important delivery technology for insulin treatment," said Stephen M. Simes, president and chief executive officer of BioSante. "This potential advance may substantially reduce the number of injections required by diabetics, thereby enhancing their quality of life."

Simes said the company plans to continue research on the new treatment as well as other delivery systems currently in development, including CAPOral(TM) for oral insulin delivery (for which the company recently received an SBIR grant) and CAPAir(TM) for inhalable insulin delivery.

CAP, BioSante`s proprietary calcium phosphate particulate technology, consists of microscopic particles of a natural compound similar to that found in teeth and bones. The patented formulation is nontoxic and biodegradable, offering a multitude of potential medical applications.

[cristrader]

Was ist nur faul an dieser Aktie?

07.10.2003
BioSante Pharmaceuticals Announces Initiation of Phase III Clinical Trial of Bio-E-Gel
http://biz.yahoo.com/bw/031007/75586_1.html

21.10.2003
BioSante Pharmaceuticals Presents Positive Interim Results Using LibiGel for Treatment of Female Sexual Dysfunction
http://biz.yahoo.com/bw/031021/215664_1.html

06.10.2003
BioSante Pharmaceuticals Reports Positive Results of Long Acting Injectable Insulin
http://biz.yahoo.com/bw/031106/65489_1.html


Kurs 02.10.2003 ===> 3,58 €
Aktuell: 07.10.2003 ===> 3,58 €

[greenhorn1998]

Geht doch!

Kurs 7. November 2003: 4,43 USD (+ 23 %)

Gruß, greenhorn

[greenhorn1998]

N`abend zusammen!

Kann mir irgendjemand sagen, ob Biosante am 12. und 13. November an einer Biotech-Konferenz teilnimmt (iBIO)? Wird im Yahoo-Board behauptet, wenn ich das richtig verstanden habe, kann aber diesbezüglich nichts finden.

Danke!

Gruß, greenhorn

P.S.: Wo steckt eigentlich Neoe?

[greenhorn1998]

Entschuldigung, Kommando zurück! Ich war mit Blindheit geschlagen.

"11. November 2003: BioSante will present at the iBIO meeting in Chicago."

Auf der Homepage von Biosante zu finden.

Gruß, greenhorn

[greenhorn1998]

Hallo zusammen!

"BioSante Pharmaceuticals, Inc. Reports on Recent Events
and Third Quarter Financial Results

LINCOLNSHIRE, Ill. -- Nov. 11, 2003 -- BioSante Pharmaceuticals, Inc. (Amex:BPA) today reported on recent corporate events and financial results for the three-month and nine-month periods ended September 30, 2003.

Recent Corporate Events

Recent highlights and important achievements include:
Moved to the American Stock Exchange, effective October 1, 2003
Closed on a $10.3 million private placement in August 2003
Reported positive results of long acting injectable insulin
Received an NIH/SBIR grant for oral insulin development
Initiated the one FDA-required pivotal Phase III trial of Bio-E-Gel(TM) (bio-identical estradiol gel) in menopausal symptoms after reporting positive Phase II/III results
Reported positive interim results of the Phase II trial of LibiGel(TM) (bio-identical testosterone gel) in female sexual dysfunction

Financial Results
The company reported a net loss of approximately $1.4 million or ($0.12) per share for the quarter ended September 30, 2003, compared to a net loss of $0.8 million or ($0.11) for the same period in 2002. For the nine month period ended September 30, the company reported a net loss of $4.3 million or ($0.43) per share compared to a net loss of $3.4 million or ($0.49) per share for the same period the prior year.

The company`s cash balance as of September 30, 2003 was approximately $10.4 million, compared to $4.9 million on December 31, 2002

About BioSante Pharmaceuticals, Inc.
BioSante is an emerging pharmaceutical company developing a pipeline of hormone therapy products to treat both men and women. BioSante is also developing its nanoparticulate-based platform technology (CAP) for novel vaccines, vaccine adjuvants and drug delivery systems. Additional information is available online at www.biosantepharma.com."

Gruß, greenhorn

[greenhorn1998]

Hallo zusammen!

Ist doch ganz schön zu beobachten, wie es in den letzten Tagen stetig bergauf gegangen ist. Vielleicht kommen ja bald wieder News, die diese Bewegung rechtfertigen bzw. diesen Trend weiter verstärken.

Gruß, greenhorn

[Neoe]

greenhorn:

Die Gründe für diesen Anstieg liegen in der Vergangenheit, wir nähern uns lediglich einer fairen Bewertung.

[greenhorn1998]

Hallo zusammen!

Wenn ich nicht irre, hat sich Biosante gestern in New Jersey präsentiert, oder? Warumgibt es bislang auf der Homepage nichts darüber zu lesen, obwohl diese Konferenz doch dort auch angekündigt war? Oder bin ich wieder zu ungeduldig?

Gruß, greenhorn

[Hackertom1]

BioSante Presents Positive Data On Inhaled Insulin
Monday December 8, 2:22 pm ET


LINCOLNSHIRE, Ill.--(BUSINESS WIRE)--Dec. 8, 2003--BioSante Pharmaceuticals, Inc. (Amex:BPA - News) today announced that it presented data on its new nanoparticulate-based technology for the delivery of insulin at the Pharmaceutical Education Associates symposium on Inhalation Drug Delivery in Princeton, New Jersey, last week.
"Among efficacy studies that evaluate various inhalable insulin formulations and are relevant for comparison, our formulation demonstrated the highest bioavailability using the smallest dose," said Dr. Tulin Morcol, associate director of drug delivery and related technologies for BioSante. The company is also developing promising new systems for the administration of insulin in oral tablet or capsule form, as well as via long-acting injection.

The presentation summarized positive results from a series of preclinical studies of the company`s BioAir(TM) calcium phosphate nanoparticulate (CAP) delivery system for inhalable insulin. The studies showed the BioSante formulation significantly increased the systemic residence time and duration of action of the insulin, increasing the amount of insulin that became available through the bloodstream (bioavailability) 1.8 times over that of injected insulin.

"We are pleased with the progress we have made toward the development of important new delivery methods for insulin and other therapies," said Stephen M. Simes, president and chief executive officer of BioSante. "The development of an inhalable insulin would represent an easy, pain-free alternative to insulin injections, allowing diabetics to live more normal, comfortable lives."

About BioSante Pharmaceuticals, Inc.

BioSante is developing a pipeline of hormone therapy products to treat both men and women. The company is also developing its nanoparticulate-based platform technology (CAP) for novel vaccines, vaccine adjuvants and drug delivery systems. Additional information is available online at www.biosantepharma.com.

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The statements regarding BioSante contained in this press release that are not historical in nature, particularly those that utilize terminology such as "may," "will," "should," "likely," "expects," "anticipates," "estimates," "believes" or "plans," or comparable terminology, are forward-looking statements. Forward-looking statements are based on current expectations and assumptions, and entail various risks and uncertainties that could cause actual results to differ materially from those expressed in such forward-looking statements. Important factors known to BioSante that cause actual results to differ materially from those expressed in such forward-looking statements are the difficulty of developing pharmaceutical products, adverse reports from others about products similar to ours, obtaining regulatory and other approvals and achieving market acceptance, and other factors identified and discussed from time to time in BioSante`s filings with the Securities and Exchange Commission, including those factors discussed on pages 17 to 23 of BioSante`s Form 10-KSB, which discussion also is incorporated herein by reference.



mfg, Hack

[Neoe]

Neuer Research-Bericht von J.M. Dutton:

http://www.jmdutton.com/Research/BISP/Reports/BPA_Report_121…

[Neoe]

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Press Release Source: BioSante Pharmaceuticals, Inc.


Webcast Alert: BioSante Pharmaceuticals Presentation at Informed Investors Biotech/Pharmaceuticals/Healthcare Stocks Forum to Be Webcast on Thursday, January 8, 2004, 9 am ET
Tuesday January 6, 9:33 am ET


LINCOLNSHIRE, Ill., Jan. 6 /PRNewswire/ -- BioSante Pharmaceuticals (Amex: BPA - News) will webcast the following presentation:
What: BioSante Pharmaceuticals (Amex: BPA - News) will give a presentation at
Informed Investors Biotechnology/Pharmaceuticals/Healthcare
Stocks Forum

When: January 8, 2004 @ 9:00 AM Eastern Time

Where: http://www.informedinvestors.com/iif_forums/forum.cfm?forumID=303" target="_blank" rel="nofollow ugc noopener">http://www.informedinvestors.com/iif_forums/forum.cfm?forumID=303

How: Live over the Internet -- Simply log on to the web at the address
above.

Contact: Phillip Donenberg, 847-478-0500, [e-mail]


If you are unable to participate during the live webcast, the call will be available for replay at http://www.informedinvestors.com/iif_forums/forum.cfm?forumID=303" target="_blank" rel="nofollow ugc noopener">http://www.informedinvestors.com/iif_forums/forum.cfm?forumID=303.

BioSante Pharmaceuticals, Inc. is an emerging pharmaceutical company developing a pipeline of hormone therapy products to treat both men and women. BioSante also is developing its nanoparticulate-based platform technology (CAP) for novel vaccines, vaccine adjuvants and drug delivery systems. Additional information is available online at www.biosantepharma.com.

FORUM CONTACT: Janet Scharr, Informed Investors, 804-327-3424, [e-mail]

Web site: http://www.informedinvestors.com

[BrauchGeld]

BioSante Pharmaceuticals Announces DynPort Subcontract to Develop Anthrax Vaccines Using Nanotechnology-Based Alternative Delivery Systems
Wednesday January 7, 12:21 pm ET


LINCOLNSHIRE, Ill.--(BUSINESS WIRE)--Jan. 7, 2004--BioSante Pharmaceuticals, Inc. (Amex: BPA - News) announced today that it has been awarded a subcontract valued at $658,207 for the development of anthrax vaccines for delivery via alternative routes of administration. The subcontract was awarded to BioSante by DynPort Vaccine Company LLC (DVC) in support of the U.S. Department of Defense Joint Vaccine Acquisition Program (JVAP).
This subcontract leverages the technology and expertise of BioSante to develop vaccines using alternative routes of administration, including nasal, oral and needle-free transcutaneous routes. Under the subcontract, BioSante will provide BioVant(TM), its proprietary nanotechnology-based vaccine adjuvant and delivery system, and DVC will provide recombinant antigens to be used in potential vaccines against anthrax. The objective is to assess the immunogenic potential of BioVant when used in anthrax vaccines versus the immunogenic response of anthrax vaccines that use Alhydrogel(TM) as the vaccine adjuvant.

BioSante is responsible for developing formulations of BioVant with the anthrax vaccine antigens and will conduct immunization studies in animals to determine the immunogenicity of the resulting BioVant/antigen vaccines compared with an anthrax vaccine formulated with Alhydrogel.

"This program is an important step toward the development of novel vaccines to protect against anthrax and takes advantage of BioSante`s work in alternative routes of administering vaccines and therapies such as insulin using our BioVant nanotechnology," said Stephen M. Simes, president and chief executive officer of BioSante. "This recognition of BioVant is further validation of the work our scientists have been conducting over the last several years and the value that has been created for our stockholders."

In June 2003, BioSante announced a Cooperative Research and Development Agreement (CRADA) with the U.S. Army`s Medical Research Institute of Infectious Diseases (USAMRIID) for development of nanotechnology-based needle-free biodefense vaccines including anthrax, bubonic plague, staph and ricin. In February 2003, BioSante announced a CRADA with the U.S. Navy`s Naval Medical Research Center to develop a nanotechnology-based vaccine for malaria.

[Neoe]

Mitllerweile dreht BioSante auf, steht jetzt bei 5,80 und außerordentlich hohes Volumen.Was kommt da wohl nur ?:


BioSante Pharmaceuticals to Present at J.M. Dutton Health Sciences Conference
Thursday January 15, 1:00 pm ET


LINCOLNSHIRE, Ill.--(BUSINESS WIRE)--Jan. 15, 2004--BioSante Pharmaceuticals, Inc. (Amex:BPA - News) announced today that its president and chief executive officer Stephen M. Simes will present at J.M. Dutton`s Health Sciences Conference in San Francisco on January 22, 2004 at 1 p.m. EST. The audio webcast will be available live, then archived for 90 days at: www.friedlandcapitalevents.com/Webcast.htm.
This J.M. Dutton conference will bring together publicly-traded companies in the pharmaceutical and biotechnology industries. During his presentation Mr. Simes will discuss BioSante`s hormone therapy products and nanotechnology being developed for improved vaccines and drug delivery. Attendees at the conference will be key members of the investment community including portfolio managers, analysts, brokers and investment bankers.

About BioSante Pharmaceuticals, Inc.

BioSante is developing a pipeline of hormone therapy products to treat both men and women. BioSante`s hormone therapy products are gel formulations for topical administration that deliver bioidentical estradiol and testosterone. Symptoms treated with hormone therapy in men include impotence, diminished sex drive, muscle weakness and osteoporosis. Symptoms in menopausal women include hot flashes, vaginal atrophy, decreased libido and osteoporosis. The estrogen and testosterone markets in the United States alone account for over $2.5 billion in annual sales. BioSante also is developing its nanotechnology (CAP) for novel vaccines, vaccine adjuvants and drug delivery systems including oral administration of proteins, such as insulin. Additional information is available online at www.biosantepharma.com.

[Neoe]

Was steckt hinter dem Kursanstieg auf 5,80 $:

BioSante Pharmaceuticals to Present at J.M. Dutton Health Sciences Conference
Thursday January 15, 1:00 pm ET


LINCOLNSHIRE, Ill.--(BUSINESS WIRE)--Jan. 15, 2004--BioSante Pharmaceuticals, Inc. (Amex:BPA - News) announced today that its president and chief executive officer Stephen M. Simes will present at J.M. Dutton`s Health Sciences Conference in San Francisco on January 22, 2004 at 1 p.m. EST. The audio webcast will be available live, then archived for 90 days at: www.friedlandcapitalevents.com/Webcast.htm.
This J.M. Dutton conference will bring together publicly-traded companies in the pharmaceutical and biotechnology industries. During his presentation Mr. Simes will discuss BioSante`s hormone therapy products and nanotechnology being developed for improved vaccines and drug delivery. Attendees at the conference will be key members of the investment community including portfolio managers, analysts, brokers and investment bankers.

About BioSante Pharmaceuticals, Inc.

BioSante is developing a pipeline of hormone therapy products to treat both men and women. BioSante`s hormone therapy products are gel formulations for topical administration that deliver bioidentical estradiol and testosterone. Symptoms treated with hormone therapy in men include impotence, diminished sex drive, muscle weakness and osteoporosis. Symptoms in menopausal women include hot flashes, vaginal atrophy, decreased libido and osteoporosis. The estrogen and testosterone markets in the United States alone account for over $2.5 billion in annual sales. BioSante also is developing its nanotechnology (CAP) for novel vaccines, vaccine adjuvants and drug delivery systems including oral administration of proteins, such as insulin. Additional information is available online at www.biosantepharma.com.

[BrauchGeld]

BioSante Announces CAP Nanotechnology Product Development and Business Update
Monday February 2, 1:26 pm ET


LINCOLNSHIRE, Ill.--(BUSINESS WIRE)--Feb. 2, 2004--BioSante Pharmaceuticals, Inc. (Amex:BPA - News) today announced an update on recent developments of its calcium phosphate-based nanotechnology (CAP).
"To date we have made significant progress in development of our proprietary CAP nanotechnology," said Stephen M. Simes, BioSante`s president and chief executive officer. "Currently, CAP nanotechnology is being developed for two lead uses, namely safer and more effective vaccines and therapeutic drug delivery, primarily proteins. We are product-focused and determined to continue to make progress in all areas."

To date, the following has been accomplished regarding development of CAP nanotechnology:

-- Product clinical and pre-clinical developments:

-- Phase I human clinical study completed, showing safety
of injected CAP.

-- Positive results in several animal models using CAP as
a safer vaccine adjuvant to improve the efficacy of
vaccines versus no adjuvant and versus alum, the only
FDA-approved vaccine adjuvant.

-- Positive results in animal models for the
sustained-release delivery of therapeutic proteins,
including long-acting injectable insulin, inhaled
insulin and oral insulin, among other proteins tested.

-- Current business and product development agreements:

-- Corixa Corporation: (non-exclusive) for use of CAP in
cancer, and infectious and autoimmune disease
vaccines.

-- U.S. Navy: (CRADA) for evaluation and development of a
malaria vaccine.

-- U.S. Army: (CRADA) for evaluation and development of
needle-free biodefense vaccines including anthrax,
staph, ricin and bubonic plague.

-- DynPort: U.S. DOD subcontract ($658,000) for
evaluation and development of a needle-free anthrax
vaccine.

-- NIH: SBIR grant ($100,000) for oral insulin
development.


BioSante scientists will be presenting at upcoming scientific meetings, including a vaccine presentation at the World Vaccine Conference 2004 in Montreal in April and on insulin at the Controlled Release Society Meeting in Honolulu in June.

BioVant(TM) is being developed as a vaccine adjuvant and delivery system for new, improved and less toxic vaccines by various routes of administration including traditional injection and alternative routes of administration, such as nasal, oral and needle-free transcutaneous routes.

In the CRADAs, which are Cooperative Research and Development Agreements, the U.S. Navy and Army have provided various vaccine antigens to be formulated with BioVant. BioSante scientists are formulating and sending the potential vaccine to the Navy or Army for pre-clinical testing. The pre-clinical testing is funded by the respective military service. In the case of the DynPort subcontract, BioSante is being provided with the vaccine antigen and will conduct the pre-clinical studies, funded by the Department of Defense.

BioOral(TM) is being developed for the oral delivery of proteins such as insulin, growth hormone and other therapeutic proteins that currently must be injected. The $100,000 National Institutes of Health grant will help fund development of an oral formulation of insulin by BioSante scientists.

The current vaccine market is approximately $9 billion and is predicted to triple in value by 2012. Interest in vaccine production is spurred by increased demand for flu vaccination, vaccines for use by tourists visiting tropical countries and fears of bioterrorism. The market for insulin is over $4 billion and increased 15.1 percent from 2001 to 2002. Diabetes affects 17 million Americans and is the country`s fifth-leading cause of death.

[BrauchGeld]

BioSante and U.S. Army Co-Developing Ricin Vaccine for Biodefense
Tuesday February 3, 1:52 pm ET


LINCOLNSHIRE, Ill.--(BUSINESS WIRE)--Feb. 3, 2004--BioSante Pharmaceuticals, Inc. (Amex:BPA - News) reiterated today its Cooperative Research and Development Agreement (CRADA) with the U.S. Army`s Medical Research Institute of Infectious Diseases for the development of a needle-free vaccine against ricin, a poisonous substance thought to have been detected in a U.S. Senate mailroom this week. BioSante has provided BioVant(TM), its proprietary nanoparticulate-based vaccine adjuvant and delivery system, and the Army has provided recombinant antigens to be used in potential vaccines against various bioterrorism agents.
The CRADA biodefense agreement was previously announced in June 2003, and also includes the development of needle-free vaccines for anthrax, staph and bubonic plague. BioVant utilizes BioSante`s proprietary calcium phosphate (CAP) nanotechnology to administer vaccines through the mucus membranes of the mouth or nasal passages, allowing the development of oral or inhaled vaccines.

[Neoe]

Wieder mal gute Neuigkeiten:


BioSante Announces CAP Nanotechnology Product Development and Business Update
Monday February 2, 1:26 pm ET


LINCOLNSHIRE, Ill.--(BUSINESS WIRE)--Feb. 2, 2004--BioSante Pharmaceuticals, Inc. (Amex:BPA - News) today announced an update on recent developments of its calcium phosphate-based nanotechnology (CAP).
"To date we have made significant progress in development of our proprietary CAP nanotechnology," said Stephen M. Simes, BioSante`s president and chief executive officer. "Currently, CAP nanotechnology is being developed for two lead uses, namely safer and more effective vaccines and therapeutic drug delivery, primarily proteins. We are product-focused and determined to continue to make progress in all areas."

To date, the following has been accomplished regarding development of CAP nanotechnology:

-- Product clinical and pre-clinical developments:

-- Phase I human clinical study completed, showing safety
of injected CAP.

-- Positive results in several animal models using CAP as
a safer vaccine adjuvant to improve the efficacy of
vaccines versus no adjuvant and versus alum, the only
FDA-approved vaccine adjuvant.

-- Positive results in animal models for the
sustained-release delivery of therapeutic proteins,
including long-acting injectable insulin, inhaled
insulin and oral insulin, among other proteins tested.

-- Current business and product development agreements:

-- Corixa Corporation: (non-exclusive) for use of CAP in
cancer, and infectious and autoimmune disease
vaccines.

-- U.S. Navy: (CRADA) for evaluation and development of a
malaria vaccine.

-- U.S. Army: (CRADA) for evaluation and development of
needle-free biodefense vaccines including anthrax,
staph, ricin and bubonic plague.

-- DynPort: U.S. DOD subcontract ($658,000) for
evaluation and development of a needle-free anthrax
vaccine.

-- NIH: SBIR grant ($100,000) for oral insulin
development.


BioSante scientists will be presenting at upcoming scientific meetings, including a vaccine presentation at the World Vaccine Conference 2004 in Montreal in April and on insulin at the Controlled Release Society Meeting in Honolulu in June.

BioVant(TM) is being developed as a vaccine adjuvant and delivery system for new, improved and less toxic vaccines by various routes of administration including traditional injection and alternative routes of administration, such as nasal, oral and needle-free transcutaneous routes.

In the CRADAs, which are Cooperative Research and Development Agreements, the U.S. Navy and Army have provided various vaccine antigens to be formulated with BioVant. BioSante scientists are formulating and sending the potential vaccine to the Navy or Army for pre-clinical testing. The pre-clinical testing is funded by the respective military service. In the case of the DynPort subcontract, BioSante is being provided with the vaccine antigen and will conduct the pre-clinical studies, funded by the Department of Defense.

BioOral(TM) is being developed for the oral delivery of proteins such as insulin, growth hormone and other therapeutic proteins that currently must be injected. The $100,000 National Institutes of Health grant will help fund development of an oral formulation of insulin by BioSante scientists.

The current vaccine market is approximately $9 billion and is predicted to triple in value by 2012. Interest in vaccine production is spurred by increased demand for flu vaccination, vaccines for use by tourists visiting tropical countries and fears of bioterrorism. The market for insulin is over $4 billion and increased 15.1 percent from 2001 to 2002. Diabetes affects 17 million Americans and is the country`s fifth-leading cause of death.

About BioSante Pharmaceuticals, Inc.

[Neoe]

Und gleich noch mehr davon:

BioSante and U.S. Army Co-Developing Ricin Vaccine for Biodefense
Tuesday February 3, 1:52 pm ET


LINCOLNSHIRE, Ill.--(BUSINESS WIRE)--Feb. 3, 2004--BioSante Pharmaceuticals, Inc. (Amex:BPA - News) reiterated today its Cooperative Research and Development Agreement (CRADA) with the U.S. Army`s Medical Research Institute of Infectious Diseases for the development of a needle-free vaccine against ricin, a poisonous substance thought to have been detected in a U.S. Senate mailroom this week. BioSante has provided BioVant(TM), its proprietary nanoparticulate-based vaccine adjuvant and delivery system, and the Army has provided recombinant antigens to be used in potential vaccines against various bioterrorism agents.
The CRADA biodefense agreement was previously announced in June 2003, and also includes the development of needle-free vaccines for anthrax, staph and bubonic plague. BioVant utilizes BioSante`s proprietary calcium phosphate (CAP) nanotechnology to administer vaccines through the mucus membranes of the mouth or nasal passages, allowing the development of oral or inhaled vaccines.

About BioSante Pharmaceuticals, Inc.

[Neoe]

Ich glaube die prompte Reaktion der Army mit BioSante einen Impfstoff gegen Rizin zu entwickeln, kurz nachdem das Gift im US-Senat gefunden wurde, zeigt, das BioSante mittlerweile die Anerkennung von ganz oben geniesst.

[Neoe]

Es wird immer besser:

BioSante CEO to Appear on CNBC`s ``Kudlow & Cramer``
Wednesday February 4, 2:25 pm ET


LINCOLNSHIRE, Ill.--(BUSINESS WIRE)--Feb. 4, 2004--BioSante Pharmaceuticals, Inc. (Amex:BPA - News) announced today that Stephen M. Simes, its chief executive officer, will appear on CNBC`s "Kudlow & Cramer" show this evening. Mr. Simes will be discussing the terror agent ricin and BioSante`s Cooperative Research and Development Agreement (CRADA) with the U.S. Army for a needle-free ricin vaccine. "Kudlow & Cramer" airs live from 5 p.m. to 6 p.m. EST, with rebroadcasts at 8 p.m. and 11 p.m. EST.
About BioSante Pharmaceuticals, Inc.

BioSante is developing a pipeline of hormone therapy products to treat both men and women. BioSante also is developing its calcium phosphate nanotechnology (CAP) for novel vaccines, vaccine adjuvants and drug delivery systems. Additional information is available online at www.biosantepharma.com.

[Neoe]

Neuer Researchbericht. Gibt nochmal einen guten Überblick über das Potential:

BIOSANTE PHARMACEUTICALS, INC.
March 26, 2004 http://www.biosantepharma.com/
AMEX: BPA
Current Quote and News

COMPANY PROFILE

BioSante Pharmaceuticals, Inc. (www.biosantepharma.com), headquartered in Lincolnshire, Illinois, is an emerging biopharmaceutical company with a late stage pipeline of gel hormone therapy products and a proprietary nanoparticulate-based platform technology for alternative methods of administering vaccines and other treatments. Human clinical trials have begun on four of its proposed transdermal gel hormone therapy products either directly by the Company or through licensees. The non-invasive products are designed to treat a variety of hormonal deficiencies in both women and men through daily topical application of gels containing substances bioidentical to natural human hormones. On the other front, the Company is developing its multi-purpose nanotechnology-based delivery system, using calcium phosphate (CAP) nanoparticles as vehicles to administer vaccines and therapeutic drugs, mainly proteins such as insulin, through nasal, oral and needle-free transcutaneous routes. The Company’s vaccine adjuvant, BioVant™, is undergoing various preclinical animal studies with commercial partners to develop vaccines for infectious diseases, and through Cooperative Research and Development Agreements (CRADA) with branches of the U.S. military to produce effective biodefense vaccines against anthrax, ricin, staph and bubonic plague. The Company also conducts partner-funded studies with BioOral™, CAP-based method to deliver insulin and other proteins without injection, as well as research to purify the milk of transgenic livestock through a patented process of isolating biologically active therapeutic proteins from their milk. Trading on American Stock Exchange under the symbol BPA, the Company is positioned to capitalize on its portfolio of hormone therapy products and the CAP delivery platform.
CURRENT PRICE: $ 4.28
52-WEEK RANGE: $1.85 - $7.11
AVERAGE DAILY VOLUME: 116,545
OUTSTANDING SHARES: 13.6 million
FLOAT: 9.5 million
INITIATING COVERAGE

HORMONE THERAPY


Market Symptoms treated with hormone therapy in men include impotence, lack of sex drive, muscle weakness and osteoporosis, and in women, menopausal and postmenopausal symptoms such as hot flashes, vaginal atrophy, decreased libido and osteoporosis. For most women, natural menopause occurs between the ages of 50 and 52. On average, a woman experiences menopause at 51 and expects to live another 30 years. Currently there are approximately 40 million menopausal women in the U.S. and this number is projected to increase by 25% over the next several years due to the aging of the baby boom generation. Also, approximately five million men in the U.S., primarily over age 40, have lower than normal levels of testosterone. The entire domestic market for hormone therapy products is estimated at $2.5 billion.


In the summer of 2002, Women`s Health Initiative (WHI), a major National Institutes of Health (NIH) research program to assess the cardiovascular effects of estrogens in postmenopausal women, stopped a clinical trial evaluating the effects of a combination estrogen-progestogen therapy due to increased risks of breast cancer and cardiovascular disease, precipitating a shift in the perception and prescription of female hormone therapy. Commercial sales of Premarin® brand products marketed by Wyeth (NYSE: WYE), including a leading estrogen-progestogen therapy Prempro™ used in the study, declined as a result. However, just this month, NIH announced it halted another even longer study using solely estrogen, this time concluding that estrogen alone does not affect heart disease risk, the major question being evaluated. These developments seem to present an opportunity for smaller pharmaceutical companies with novel hormone therapy products, which were already expected to increase their market share according to last year’s research reports from Datamonitor, a leading global strategic market analysis company.


Current methods for hormone delivery in the case of testosterone include injections, dermal patches and gels, whereas estrogen is delivered orally as pills or tablets, through dermal patches and other transdermal or transmucosal methods such as subcutaneous implants and vaginal suppositories. Side effects experienced with the use of oral estrogen in pill or tablet form include insufficient absorption by the circulatory system, gallstones and blood clots. At the same time, skin patches have often been associated with skin irritation, both in male and female dermal products.


Product Development The Company is developing a pipeline of late stage hormone therapy products, mostly licensed on an exclusive basis from Antares Pharma, Inc. (OTC BB: ANTR), for the treatment of human hormone deficiencies. The Company’s sex-specific transdermal gel formulations contain testosterone or estradiol, a natural form of estrogen, as well as appropriate combinations of testosterone, estradiol and norethindrone, a form of progestogen, another female hormone which has been shown to reduce the potential risks of uterine hyperplasia or cancer associated with isolated estrogen therapy. The products include (i) Bio-T-Gel™ - a testosterone gel for treatment of hypogonadism, or testosterone deficiency, in men, (ii) Bio-E-Gel™ - an estrogen gel for treatment of menopausal symptoms in women, (iii) LibiGel™ - a testosterone gel for treatment of female sexual dysfunction (FSD), (iv) Bio-E/P-Gel™ - a combination of estrogen and a progestogen for treatment of menopausal symptoms in women, and (v) LibiGel-E/T™ - a combination of estrogen and testosterone for treatment of FSD in menopausal women. Applied once daily on the arms, shoulders, abdomen or thighs, the clear gels are quickly absorbed through the skin without a trace of residue, delivering the required hormone to the bloodstream evenly and in a non-invasive, painless manner that limits irritation problems. The testosterone and estradiol products deliver hormones bioidentical to natural ones.


Several of the Company’s hormone therapy products are undergoing Phase II or III human clinical trials. The Company has signed a license agreement with Teva Pharmaceuticals USA, Inc., a wholly owned subsidiary of Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) to commercialize a hormone therapy product in the U.S. market. Under the development and license agreement, Teva is responsible for continued development, regulatory filings, manufacturing and marketing and will pay the Company royalties on potential product sales, in addition to a $1.5 million upfront payment already received. The Company also sub-licensed its U.S. and Canadian markets rights for Bio-E/P-Gel™ to Solvay Pharmaceuticals, B.V., a subsidiary of the Solvay S.A. group, which employs about 32,000 people in 50 countries and is headquartered in Brussels, Belgium. Solvay is responsible for all costs of development and marketing for the product, while the Company retains certain co-promotion rights and, in addition to a received initial payment of $2.5 million, will be compensated through future milestone payments ($950,000 received to date) and escalating sales-based royalties. The Company also sub-licensed marketing rights to its single entity hormone therapy products for the Canadian market to Paladin Labs, Inc. (TSX: PLB), in exchange for a $500,000 investment, future milestone payments and royalties, and is planning to further sub-license the hormone therapy line to companies in other countries for which it holds rights, including Mexico, New Zealand, Malaysia, Australia, Indonesia, Israel, China and South Africa.



CAP DELIVERY PLATFORM


Technology Based on its license from the University of California, the Company has developed a novel delivery system technology based on calcium phosphate (CAP) nanoparticles, non-toxic biodegradable materials measuring less than 1,000 nanometers, or one thousandth of a millimeter. The platform, which supports unhindered biological activity of attached vaccine components like bacterial or viral antigens or proteins like insulin, can be developed for safer and more effective vaccines and therapeutics drug delivery systems. Due to the small size of the particles, the technology also makes feasible alternative routes of administration, including nasal, oral and needle-free transcutaneous methods.


BioVant™ The Company’s nanotechnology-based vaccine adjuvant, BioVant™, has been tested in comparison to aluminum hydroxide or alum, the only currently available adjuvant approved by the U.S. Food & Drug Administration (FDA) for human use. When combined with vaccines in animal studies, BioVant™ elicits a higher immune response than non-adjuvanted vaccines and an immune response of the same or better magnitude as alum-formulated vaccines. The Company has also successfully completed a Phase I human clinical trial of its CAP technology as a vaccine adjuvant and delivery system and is currently collaborating with various partners to develop commercial product applications.


The Company has a non-exclusive license agreement with Corixa Corporation to use BioVant™ for a variety of cancer, infectious and auto immune disease vaccines being developed by Corixa. In February 2003, the Company entered into a Cooperative Research and Development Agreement (CRADA) with the U.S. Navy`s Naval Medical Research Center to develop a vaccine for malaria using BioVant™. Later in June, the Company announced another CRADA with the U.S. Army`s Medical Research Institute of Infectious Diseases for development of needle-free biodefense vaccines including anthrax, ricin, staph and bubonic plague. The Company has also been awarded a subcontract by DynPort Vaccine Company LLC (DVC), in support of the U.S. Department of Defense Joint Vaccine Acquisition Program, to provide BioVant™ for potential needle-free vaccines against anthrax using recombinant antigens provided by DVC. The research will potentially provide further evidence of BioVant™’s viable immunogenicity in comparison to Alhydrogel™, an existing anthrax vaccine adjuvant.


Most vaccines require the use of adjuvants to generate adequate protective immunity to prevent or treat diseases and there is only one FDA-approved adjuvant on the market. At the same time, revitalized by new technology, the vaccine market recently experienced increasing annual growth rates that approached 10% during the late 1990s. According to Datamonitor, a global strategic market analysis company, continuing annual growth rates of 10-12% will result in a $17 billion global vaccine market by 2010. In addition, Business Communications Company, Inc., another specialized market research firm, sees a bright future for DNA- and protein-based therapeutic vaccines, ideal candidates for use with BioVant™.


BioAir™ and BioOral™ The Company also applies its nanotechnology platform for development of alternative methods for delivery of proteins that must be administered by injection. The lead application of this technology is for insulin delivery for diabetics, including inhalable BioAir™ system and oral tablet or capsule form product, BioOral™. Diabetes is a disease in which the body does not produce or properly use insulin, a hormone needed to convert sugar, starches and other food into energy needed for daily life. The cause of diabetes continues to be a mystery, although both genetics and environmental factors such as obesity and lack of exercise appear to play roles. Comparing to injections, both of the Company’s products would represent an easy, pain-free alternative allowing diabetics to live more normal, comfortable lives.


Diabetes is the seventh-leading cause of death, and is on the rise due to increasing obesity in both developed and developing countries. There are 18.2 million people in the United States, or 6.3% of the population, who have diabetes. Worldwide, the patient population is projected to grow from 39.4 million in 2003 to 49.4 million people, or over 25%, in 2010. By then, the sales of two most advanced inhaled insulin products still under development, AERx® developed by Aradigm Corporation (Nasdaq: ARDM) and Exubera® by Nektar Therapeutics, are expected to reach a level of $1.9 billion combined, according to Datamonitor. For type 1 diabetes, the body`s failure to produce insulin, the only effective treatment remains painful insulin injections. Type 2 diabetics, the body failure to properly use insulin, can take oral drugs, but over time most end up needing insulin injections to control their disease. As such, insulin syringes still have the largest patient base, holding greater than 90 percent of the total patient market share. Nevertheless, revenue growth for the syringe market is small from year to year. Newly diagnosed diabetics are more likely to adopt injection pen, infusion pump or other new inhalable and oral technologies than use syringes. Hence, the key unmet need in the diabetes market is centered around drug delivery formulations.


The Company has completed a series of preclinical studies of BioAir™ and BioOral™ delivery systems and most recently presented research data at the Pharmaceutical Education Associates symposium on Inhalation Drug Delivery in Princeton, New Jersey, in December last year. The BioAir™ formulation significantly increased the systemic residence time and duration of action of the insulin, increasing the bioavailability, or the amount of insulin that became available through the bloodstream, 1.8 times over that of injected insulin. BioAir™ also demonstrates the highest bioavailability versus other inhalable insulin formulations relevant for comparison, using the smallest dose.


Over and beyond insulin, drug delivery is one of the most important drivers in the rapidly changing pharmaceutical industry. According to a study by Kalorama Information, a publisher of life science market research reports, delivery technologies themselves accounted for 16% of total revenues in the $2.4 billion oral delivery market in 2000, with the rest attributable to sales of the pharmaceutical being delivered. But by 2005, the technology component will soar to over 40% of the total, in a market worth almost $30 billion. Furthermore, Kalorama Information reports that the market for drugs employing advanced drug delivery technologies, such as nanoparticulates, itself will surpass $7 billion by 2005, with revenues attributable to the delivery technologies gaining ground faster than the segment, which has seen consistent double-digit growth as a whole in the past few years.


Therapeutic Protein Isolation In addition to hormone therapy and drug delivery, the Company has been issued a U.S. patent for its CAP technology to be used as a mechanism for selectively isolating biologically active commercially viable yields of therapeutic proteins from milk of transgenic animals, a challenging task that could improve cost-effectiveness of many pharmaceuticals when overcome. The Company is looking for a partner to license out the development and production of its technology for this purpose.



COMPETITION


Due to the relative diversification of its product pipeline, the Company competes in several pharmaceutical segments, but often most closely with companies that share its harmonious strategy. For example, in addition to hormonal products, Novavax, Inc. (NASDAQ: NVAX) is developing a proprietary drug delivery and vaccine technologies for women`s healthcare and infectious diseases, while Noven Pharmaceuticals, Inc. (NASDAQ: NOVN) works on other applications of its transdermal drug delivery technologies already used for menopausal treatment. Antares Pharma, Inc. (OTC BB: ANTR), which primarily produces needle-free injectors, is still also committed to other drug delivery methods such as its topical gel formulations. In addition to various smaller firms like Cellegy Pharmaceuticals, Inc. (NASDAQ: CLGY) and Auxillium Pharmaceuticals, Inc., the hormone therapy marketplace is penetrated by large drug companies, such as Wyeth (NYSE: WYE). At the same time, the vaccines market is also dominated by giants like Merck & Co., Inc. (NYSE: MRK) and GlaxoSmithKline plc (NYSE: GSK).


MANAGEMENT


The Company’s management team has a wealth of product development, clinical and executive experience.


Stephen M. Simes, Vice Chairman, President and CEO, is an established leader with 30 years of experience in the biopharmaceutical industry. Prior to joining the Company in 1998, Mr. Simes was President and CEO of Unimed Pharmaceuticals, Inc., a company focused on infectious diseases, AIDS, endocrinology and oncology, and currently operating as a wholly-owned subsidiary of Solvay Pharmaceuticals, Inc. belonging to a Brussels, Belgium based Solvay Group. Previously, Mr. Simes was Chairman, President and CEO of Gynex Pharmaceuticals, Inc., a company which concentrated on AIDS, endocrinology, urology and growth disorders markets, later acquired by Bio-Technology General Corp., which is currently known as Savient Pharmaceuticals, Inc. (NASDAQ: SVNT). Mr. Simes` career in the pharmaceutical industry started in 1974 with G.D. Searle & Co. He also holds an MBA from New York University.


The Company’s CFO, Treasurer and Secretary, Phillip B. Donenberg, CPA, has held a variety of executive positions at several biotechnology and pharmaceutical companies, most recently serving as a Controller of Unimed Pharmaceuticals, Inc. and Molecular Geriatrics Corporation, and previously at Gynex Pharmaceuticals, Inc. and Xtramedics, Inc.


The Company’s vaccine and oral delivery product development is coordinated by Steven J. Bell, Ph.D., VP of Research and Pre-Clinical Development, who in his career has held various positions at such world-class companies as Boehringer Mannheim, Hoffman-LaRoche, The Upjohn Company (NYSE: UPJ) and Boehringer Ingelheim. Leah M. Lehman, Ph.D., VP of Clinical and Regulatory Affairs, who is responsible for the Company’s hormone therapy products, prior to joining the Company was Director of Clinical Research with Scientific Research Development Corp. and previously worked as a clinical statistician at Abbott Laboratories.


The Company also has a distinguished and active Board of Directors led by Chairman Louis W. Sullivan, M.D.,


President Emeritus of the Morehouse School of Medicine, Atlanta, Georgia, who served four years as Secretary of Health and Human Services during the Bush Administration (1989-1993) and holds Director positions on the boards of Bristol-Myers Squibb Co. (NYSE: BMY) and 3M Co. (NYSE: MMM), among other well known companies.



FINANCIAL OUTLOOK


All of the Company’s revenue to date has been derived from upfront and milestone payments earned on licensing and sub-licensing transactions, as well as interest earned on invested funds. For the year ended December 31, 2003, the Company incurred a net loss of approximately $6.0 million, or $0.54 per share, compared to a net loss of $3.8 million, or $0.51 per share, for the same period in 2002. The overall increase in net loss was largely attributable to an absence of non-recurring licensing revenue payments received in 2002.


Since inception, the Company has raised approximately $31 million in equity financing, including conversion of debentures and warrants. With a solid track record of raising funds and no long term debt, the Company appears well positioned to continue its product development and advancement of its clinical trials. In August 2003, the Company raised $10.3 million in a private placement offering of 4.8 million units consisting of one common share and one half warrant, serving as a continuing validation of the progress achieved over the last several years by the Company and the value that has been created for stockholders. On October 1, 2003, the Company`s common stock began trading on the American Stock Exchange. As of December 31, 2003, the Company had $9.1 million cash on hand. Although the monthly burn rate in 2004 is expected to rise above the 2003 average level of approximately $500,000 due to increased development spending associated with the hormone therapy clinical trials, the management believes the current cash resources will be sufficient to fund operations through at least the next twelve months.


The Company’s shares present a good long term bet for speculative investors willing to accept the very high risks associated with emerging biotechnology companies, such as the lack of liquidity and price volatility, as well as current lack of profitability, likelihood of dilution, the uncertainty of success in product development and intense competition within the industry. Milestones that have a potential to increase the stockholder value within the next twelve months include completion of the Phase III Bio-E-Gel™ study and filing for FDA approval for Bio-E-Gel™ and Bio-T-Gel™, further progress in LibiGel™ clinical trials or announcement of additional collaborations for the CAP technology in delivery of vaccines or therapeutics proteins, including the Company’s insulin project.



Alan Stone, Managing Director

[BrauchGeld]

Cool

BioSante Pharmaceuticals Listed on Merrill Lynch, Punk Ziegel Nanotechnology Stock Indices
Wednesday April 7, 12:18 pm ET


LINCOLNSHIRE, Ill.--(BUSINESS WIRE)--April 7, 2004--BioSante Pharmaceuticals, Inc. (Amex:BPA - News) announced today that the investment firms Merrill Lynch and Punk, Ziegel & Company have included BioSante in their respective indices of nanotechnology companies.
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"This is a key acknowledgment and validation of the important work we are doing with our calcium phosphate nanotechnology for drug delivery and vaccines," said Stephen M. Simes, president and chief executive officer of BioSante. "We are continuing to achieve important advances with this exclusive and innovative nanotechnology, which now appears to offer substantial potential for increasing stockholder value."

Merrill Lynch included BioSante on an index (Amex:NNZ - News) of 25 "pure play" nanotech companies in its March 31 report on the nanotechnology sector. Punk, Ziegel & Company included BioSante in its recently launched Nanotechnology Index (http://punkziegel.com/nanotech2.php) of 15 publicly traded companies in this sector.

BioSante`s nanotechnology, known as CAP, consists of microscopic particles of material similar to calcium phosphate, a natural compound found in teeth and bones. CAP is nontoxic and biodegradable, offering a multitude of potential medical uses. BioSante`s formulation contains nanoparticles of roughly uniform size, between approximately 100 and 1,000 nanometers, which can be adjusted in the manufacturing process.

BioSante is developing CAP for several applications, including its use as a superior alternative to aluminum salts (alum) as an adjuvant for potential vaccines. An adjuvant is a substance that enhances the immunogenicity, and thus the efficacy, of a vaccine. In addition, the company is now working with the U.S. Navy, U.S. Army and Department of Defense to develop non-injected vaccines to protect against malaria, anthrax, ricin, staph and bubonic plague based on the CAP nanotechnology.

"Because of their microscopic size, CAP nanoparticles also have proven very effective for improved delivery methods for therapeutic proteins that currently must be injected, such as insulin," Simes said. To date the company has successfully completed preclinical trials of formulations for the delivery of therapeutic proteins, including long-acting insulin injections, inhaled insulin and oral insulin, among other proteins tested.

[Neoe]

BUY-Rating eines neuen Analysten (was auch immer man von ihnen hält):

http://finance.yahoo.com/q/ud?s=BPA

[Falke28]

Nette Aktie und saubere Analyse Neoe!

Gruß
Falke28

[Neoe]

BioSante Pharmaceuticals Announces Notice of Allowance For CAP Nanotechnology Patent by European Patent Office
Tuesday April 20, 9:01 am ET


LINCOLNSHIRE, Ill.--(BUSINESS WIRE)--April 20, 2004--BioSante Pharmaceuticals (Amex:BPA - News) announced today that it has received a notice of allowance from the European Patent Office (EPO) accepting BioSante`s patent application for the manufacturing process of the company`s unique calcium phosphate nanoparticles (CAP).
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The EPO has stated that it intends to grant patent protection covering BioSante`s proprietary manufacturing process for its CAP nanoparticles, including its manufacture with antigens for vaccines and therapeutic proteins. The company was awarded a patent on the manufacturing process for its CAP nanoparticles in the United States in 2002.

"The notice from the EPO significantly expands the intellectual property protection of our exclusive CAP nanotechnology. CAP continues to demonstrate both its potential as a novel and versatile therapeutic drug and small molecule delivery system, as well as a parenteral and mucosal vaccine adjuvant," said Stephen M. Simes, president and chief executive officer of BioSante. "CAP is expected to play a valuable role in a wide range of prophylactic and therapeutic medical applications."

BioSante`s CAP nanotechnology consists of microscopic particles of calcium phosphate, which is similar to the calcium phosphate found in teeth and bones, and is biocompatible and nontoxic. BioSante`s innovative formulation consists of nanoparticles of roughly uniform size, between approximately 100 and 1,000 nanometers -- size can be selectively adjusted in the manufacturing process to suit the array of defined biomedical applications.

BioSante now is developing CAP for a growing range of applications, including its use as a superior alternative to aluminum salts (alum) as an adjuvant to enhance the immunogenicity and corresponding effectiveness of vaccines. Alum is currently the only vaccine adjuvant approved for human use; however it has several drawbacks that may be overcome with CAP, including irritation and inflammation at the injection site and limited utility against intracellular pathogens such as viruses. CAP also may serve as a vaccine delivery system for non-injected vaccines.

"We now are working with the U.S. Navy, Army and Department of Defense to use our CAP technology to develop non-injected vaccines that protect against malaria, anthrax, ricin, staph and bubonic plague," Simes said. "In addition, because of CAP`s microscopic size, it is also very effective for the improved administration and sustained-release of therapeutic proteins that currently must be injected, such as insulin."

To date, BioSante has successfully completed preclinical trials of CAP formulations for long-acting insulin injections, inhaled insulin and oral insulin, among other proteins. CAP also has been shown to be "safe and non-toxic" after subcutaneous administration in a Phase I human clinical trial.

[Neoe]

BioSante Pharmaceuticals Announces Positive Results of CAP Adjuvant Study in CDC Collaboration
Thursday April 29, 10:00 am ET


LINCOLNSHIRE, Ill.--(BUSINESS WIRE)--April 29, 2004--BioSante Pharmaceuticals, Inc. (Amex:BPA - News) today announced that a comparative preclinical study demonstrated its calcium phosphate (CAP) nanotechnology-based vaccine adjuvant, BioVant(TM), may be more effective than aluminum salt derivatives (alum), the only adjuvant currently approved by the Food and Drug Administration (FDA). The study was conducted in collaboration with the U.S. Centers for Disease Control and Prevention (CDC) in a previously unannounced BioSante collaboration. The results will be presented today at the World Vaccine Congress in Montreal.
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"These positive study results contribute to the growing body of evidence that BioVant is an effective alternative to alum for the enhancement of immune system response to vaccines," said Stephen M. Simes, president and chief executive officer of BioSante. "Moreover, in contrast to non-biodegradable, non-biocompatible alum, our CAP nanoparticles are easily degraded in the body with no ill effects, and have been shown in an FDA-approved trial to be `safe and nontoxic` to humans."

In addition to a BioVant formulation that promotes a Th1 (antiviral) immune response, BioSante researchers recently developed a formulation of the adjuvant that produces a Th2 (antibacterial) response. Both formulations were tested in this study, along with alum.

The study`s objective was to assess the comparative efficacy of various vaccine adjuvants in eliciting cellular and humoral immune responses to a recombinant circumsporozoite protein (CSP) from the infectious (sporozoite) stage of malaria contracted from biting mosquitoes. Mice were injected either twice or three times, each inoculation 15 days apart, with CSP alone (controls) or with vaccine formulations containing aluminum hydroxide (alum), CAP-Th1 or CAP-Th2 adjuvants. The mice were monitored and their blood was tested at three different times to determine antibody levels.

After three inoculations with the respective adjuvanted malaria vaccine formulations, CAP-Th2 produced an immune response four times greater than that of alum.

"This study shows that BioVant is a non-aluminum adjuvant that enhances pathogen-specific immune responses of comparable or greater potency compared to the only adjuvant currently approved for use in humans, namely the aluminum adjuvant," said Dr. Steve J. Bell, vice president of research and preclinical development for BioSante. "We are very encouraged by these results and will continue to develop this potentially vital new weapon in the fight against infectious disease."

An adjuvant is a substance that, when added to a vaccine, enhances the vaccine`s effect by stimulating an immune system response. While aluminum salt derivatives, such as alum, are the only adjuvants currently approved by the FDA, alum has been associated with adverse reactions such as irritation and inflammation of the injection site, and may also result in an allergic reaction.

In contrast, BioVant is composed of specially formulated calcium phosphate, a naturally occurring compound similar to that found in teeth and bones. In multiple studies, BioVant has been shown not to cause inflammation at the injection site, and no allergic response has been observed.

Another drawback of alum is the type of immune reaction it typically triggers. Alum primarily promotes a particular subset of T-helper cells, known as Th2 cells, which target extracellular bacterial infections but tend not to be optimal for fighting viral infections. BioVant, on the other hand, elicits a biased Th1 cell response with concurrent Th2 response, the combination of which activates T lymphocytes that destroy virally infected cells and which promotes antibody immunity -- or can be adjusted to produce either type of response. In this way, the two adjuvants may serve as complements to each other.

"We believe CAP, in the form of BioVant, shows potential to be an important adjuvant for the next generation of vaccines against both viral and bacterial infections," Simes said. "BioSante and several commercial and military partners are now conducting additional pre-clinical studies of BioVant in several potential vaccines, and the company is pursuing additional licenses for further development of CAP in all areas."

BioSante has licensed its BioVant adjuvant to Corixa Corporation on a nonexclusive basis for use in a variety of vaccines. The company is also working with the U.S. Navy and Army and the U.S. Department of Defense to develop vaccines against malaria, anthrax, ricin, staph and the bubonic plague.

[Neoe]

BioSante Pharmaceuticals Announces $17.7 Million Private Placement ofCommon Stock

LINCOLNSHIRE, Ill., May 12, 2004 (BUSINESS WIRE) -- BioSante Pharmaceuticals, Inc. (Amex:BPA) today announced that it has entered into definitive agreements with institutional and other accredited investors with respect to the private placement of 2,949,000 shares of its common stock at a purchase price of $6.00 per share, for gross proceeds of $17,694,000. Investors also will receive warrants to purchase 442,350 shares of common stock at an exercise price of $7.00 per share. Leerink Swann & Company served as placement agent for the transaction

The transaction is expected to be consummated within the next few days following satisfaction of certain customary closing conditions contained in the definitive transaction agreements, including approval of an additional listing application with the American Stock Exchange.

"We are pleased by this exciting private placement, and are gratified to welcome a new group of institutional investors who we believe will help us increase the company`s visibility in the investment community," said Stephen M. Simes, BioSante`s president and chief executive officer. "The additional cash will be used to implement our plan to build a valuable portfolio of hormone therapy products and continue development of our CAP nanotechnology. Including the proceeds from this placement, we will have about $25 million in the bank, which is equal to more than two years of our cash requirements."

The net proceeds to BioSante will be approximately $16.5 million. BioSante intends to use the net proceeds to fund the late stage development of the company`s new product pipeline, including Bio-E-Gel(TM), currently in its pivotal Phase III clinical trial to treat menopausal symptoms, and LibiGel(TM), soon to complete a Phase II clinical trial for Female Sexual Dysfunction, as well as for general corporate purposes.

The securities offered in this placement have not been registered under the Securities Act of 1933, as amended, or state securities laws, and cannot be offered or sold in the United States absent registration with the Securities and Exchange Commission (SEC) or an applicable exemption from the registration requirements. As part of the transaction, the company has agreed to file a registration statement with the SEC covering the resale of the shares of common stock issued in the offering, including the shares of common stock issuable upon exercise of the warrants. This news release is neither an offer to sell nor a solicitation of an offer to buy any of the securities discussed herein and is being issued under Rule 135c of the Securities Act of 1933.

About BioSante Pharmaceuticals, Inc.

BioSante is developing a pipeline of hormone therapy products to treat both men and women. BioSante`s hormone therapy products are gel formulations for transdermal administration that deliver bioidentical estradiol and testosterone. Symptoms treated with hormone therapy in men include impotence, diminished sex drive, muscle weakness and osteoporosis. Symptoms in menopausal women include hot flashes, vaginal atrophy, decreased libido and osteoporosis. The estrogen and testosterone markets in the United States alone account for over $2.5 billion in annual sales.

The company also is developing its calcium phosphate nanotechnology (CAP) for novel vaccines, including biodefense vaccines for toxins such as anthrax and ricin, and drug delivery systems. Additional information is available online at www.biosantepharma.com.

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The statements regarding BioSante contained in this press release that are not historical in nature, particularly those that utilize terminology such as "may," "will," "should," "likely," "expects," "anticipates," "estimates," "believes" or "plans," or comparable terminology, are forward-looking statements. Forward-looking statements are based on current expectations and assumptions, and entail various risks and uncertainties that could cause actual results to differ materially from those expressed in such forward-looking statements. Important factors known to BioSante that cause actual results to differ materially from those expressed in such forward-looking statements are the difficulty of developing pharmaceutical products and especially of new vaccines, obtaining regulatory and other approvals and achieving market acceptance, and other factors identified and discussed from time to time in BioSante`s filings with the Securities and Exchange Commission, including those factors discussed on pages 18 to 25 of BioSante`s Form 10-KSB, which discussion also is incorporated herein by reference.

SOURCE: BioSante Pharmaceuticals, Inc.


CONTACT: BioSante Pharmaceuticals, Inc.
Phillip B. Donenberg, 847-478-0500 ext 101
[e-mail]

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[BrauchGeld]

Hi
Biosante ist für mich wirklich ein Top investment.

Form 8-K for BIOSANTE PHARMACEUTICALS INC


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

1-Sep-2004

Entry Material Agreement, Financial Statements and Exhibits



Item 1.01 Entry into a Material Definitive Agreement
On August 27, 2004, BioSante Pharmaceuticals, Inc. entered into a Second Amendment to Lease with Highlands Park Associates effective as of September 1, 2004. The Amendment amends the Lease, dated as of September 15, 1997, as amended, between BioSante and Highlands Park Associates. The Amendment is filed as Exhibit 10.1 to this report and is incorporated herein by this reference.

The Amendment, among other things:

• extended the term of the Lease, as amended, from October 31, 2004 to October 31, 2006;

• decreased the monthly minimum base rent from approximately $7,300 per month to approximately $6,018 per month;

• set November 1, 2005, as the next date for a minimum base rent increase;

• provided for an additional security deposit payment of $20,000; and

• eliminated the right of either BioSante or Highlands Park Associates to terminate the Lease, as amended, prior to the end of the term by giving the other party at least 60 days prior written notice.

Section 9 - Financial Statements and Exhibits





Item 9.01 Financial Statements and Exhibits
(c) Exhibits. The following exhibits is filed herewith:


Exhibit No. Description

10.1 Second Amendment to Lease dated as of September 1, 2004, by and
between BioSante Pharmaceuticals, Inc. and Highlands Park
Associates.

[BrauchGeld]

hi leute

William Blair & Company Initiates Coverage of BioSante Pharmaceuticals, Inc. With Outperform Rating
Wednesday September 15, 12:53 pm ET


CHICAGO, Sept. 15 /PRNewswire/ -- William Blair & Company today announced that it initiated research coverage of BioSante Pharmaceuticals, Inc. (Amex: BPA - News; $7.85), a developmental-stage company building a portfolio of hormone therapy (HT) products for men and women, with an Outperform rating and company profile of Aggressive Growth.
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Analyst Richard Watson estimates that the company, which also is in early development for its proprietary calcium phosphate technology that can be used for the novel delivery of vaccines and proteins, will turn profitable during 2007.

"We believe the potential value of the company`s pipeline of HT product candidates, which address several large and growing markets, is not fully reflected in the current stock price, and we therefore recommend purchase for risk-tolerant investors," Watson said. "While several other companies have HT products in development or on the market, BioSante`s gel formulations offer certain advantages over other therapies and address multiple segments of the HT market, in our view. Moreover, because the company`s product candidates employ active ingredients with established safety and efficacy profiles, we believe the development risks associated with BioSante`s pipeline are arguably below pharmaceutical industry averages."

Among BioSante`s product lineup are Bio-E-Gel, a once-daily transdermal gel formulation of bioidentical estradiol in Phase III development for the treatment of menopausal symptoms in women; Bio-T-Gel, a once-daily transdermal bioidentical testosterone gel in late-stage clinical development for the treatment of male hypogonadism; and LibiGel, a once-daily transdermal gel formulation of bioidentical testosterone that has recently completed Phase II development and likely will enter Phase III development in first quarter 2005 for the treatment of female sexual dysfunction.

Gruss
B.M.

[BrauchGeld]

Hi

Ist wirklich schön an zusehen wie sich Biosante die letzten tage entwickelt hat .
Die Aktie ist in den letzten 3-4 tage unter hohen volumen gestiegen(siehe Tabelle) anscheinend stehen News bald an .Mit 4 produkten in Phase 3 ist die aktie immer noch sehr billig.

PRICES

Date Open High Low Close Volume Adj Close*
16-Sep-04 8.28 8.70 8.20 8.70 302,900 8.70
15-Sep-04 8.00 8.55 7.98 8.23 479,100 8.23
14-Sep-04 7.50 7.90 7.50 7.85 320,300 7.85
13-Sep-04 7.10 7.50 7.00 7.50 287,300 7.50
10-Sep-04 7.10 7.18 7.10 7.10 15,800 7.10
9-Sep-04 7.25 7.25 6.85 7.10 51,000 7.10
8-Sep-04 7.25 7.35 7.16 7.25 12,600 7.25
7-Sep-04 7.30 7.41 7.20 7.30 32,900 7.30
3-Sep-04 7.30 7.37 7.30 7.30 40,900 7.30
2-Sep-04 7.25 7.38 7.25 7.31 51,000 7.31
1-Sep-04 6.90 7.38 6.90 7.24 189,500 7.24

Gruss
B.M.

[Neoe]

Bin schon vor einiger Zeit bei 8 Dollar ausgestiegen, habe ehrlich gesagt nicht erwartet, dass sie da so schnell nochmal darüber gehen. Bist du im Moment einer der Glücklichen, die drin sind ?

[BrauchGeld]

Gude Neoe

Hätte nicht gedacht das du diese Perle zu dem schleuderpreis verkäufst.
Für mich ist Biosante einer der aussichtsreichsten Biotech Aktien überhaupt .
Biosante hat super produkte in der Pipeline und mit Teva Pharma einen super partner .
Also ich verkaufe ab 50$ vorher brauch man gar net drüber sprechen.

Gruss
B.M.

PS: Schau Dir mal Depomed (Depo)an diese Aktie wird der renner mit 2 Produkten (Glumetza für typ 2 Diabetes und Proquin ein Antibiotikum) die auf die Zulassung warten beide Produkte zielen auf ein milliarden Markt.

[Neoe]

Hi BrauchGeld:

Hab mir Depomed schon angeschaut, könnte ebenfalls ein Hammer werden, wie so viele unterbewertete Biotechs dieser Tage. Hätte ich bloß noch 100000 Euro auf der hohen Kante, dann könnte ich nächstes Jahr in Rente gehen...

Hab mich jetzt aber nach genauem hinschauen auf Maxim festgelegt. Im Vergleich zu Depomed hängt Maxim bei der Markteinführung nicht zwangsläufig von großen Partner ab.
Außerdem befürchte ich, daß nach Einführung des inhalierbaren Insulins durch Aventis und Pfizer die Konkurrenz nicht mehr viel zu lachen hat.
Trotzdem ist sicher auch mit Depomed die ein oder andere Mark zu verdienen.
Zu alledem sieht der Balance Sheet von Maxim bei weitem stabiler aus. Eigenkapitalquote liegt bei 85%. Cash 65 Millionen.


Jetzt aber zum eigentlichen Thema Biosante:

Da ich hier schon zu OTCBB-Zeiten eingestiegen bin, hat sich der Ausstieg bei 8 Dollar gelohnt.
Das Hormonpräparat (Bio-E-Gel) ist meiner Meinung nach der Zeit hinterher (siehe Solvay und vor allem Novavax).

Libigel wird noch einige Zeit brauchen, wenn sie das wie angekündigt selbst entwickeln wollen, wird hier noch einiges an Kapital fließen müssen und die Konkurrenz wird in diesem Gebiet groß werden (Procter&Gamble, Novavax, Palatin, etc.) Trotzdem ein tolles Produkt, aber beim heutigen Kurs (immer im Vergleich zu den Biotech-Kursen allgemein) angemessen eingepreist.

Bleibt noch die Nanotech-Sparte, eine Perle, die schlecht zu bewerten ist. Aufgrund der neuen Regeln der FDA kann der Wert dieses Bereiches schnell zulegen. Ebenfalls nicht zu vergessen die Gelder , die durch den BioShield-Deal fließen könnten. Biosante hat hervorragende Kontakte in den entscheidenden Gremien. Also Fantasie ist da, aber für mich derzeit nicht so eindeutig sichtbar.

Meiner Meinung hat DerSchweizer mit Maxim den absoluten Hammer der Saison ausgegraben. Zum ersten Mal wurde ich glaube ich in deinem Spectrum-Thread (übrigens auch sehr interessantes Unternehmen) darauf aufmerksam, hab aber erst nach seinem Posting im LateStage-Thread nochmal genauer hingeschaut: $$$$$$$$ (potentieller Short-Squeeze des Jahres) + plus Zockerschweisausbruch-Garantie + Blockbuster-Fantasie + Neubewertungsfantasie + Anti-Langeweile-Faktor (konstanter Newsflow bis Mitte 2005) = Ideale Spielwiese für Hardcore-Zocker bis Langfristanleger.

[BrauchGeld]

Hallo !

BioSante Satisfied to Be Second

By Adam Feuerstein
Senior Writer
9/20/2004 8:00 AM EDT
Click here for more stories by Adam Feuerstein

BioSante Pharmaceuticals (BPA:Amex - commentary - research) is a sexy stock.

The standout opportunity amidst the small drug company`s well-stocked pipeline of hormone therapy products is a testosterone gel that, if approved for sale, would be used by menopausal women to boost their flagging sex drive.


The commercial market for legitimate products to treat "female sexual dysfunction" barely exists today. This stands in stark contrast to the mountains of cash forked over by men for drugs like Viagra, Cialis and Levitra.

But gender inequality over sexual dysfunction treatments is about to change, which puts BioSante in a sweet spot. And at a current stock price of $8.91 and a market cap of $164 million, the company is both underappreciated by investors and undervalued given the significant commercial potential for products like LibiGel.

There are a bunch of reasons to like the BioSante story. For starters, there is well-established science behind LibiGel, and with that foundation comes a relatively lower risk that the product blows up. Doctors have long understood that a lower-than-normal level of the hormone testosterone contributes to a waning desire for sex in women, especially women nearing, or in, menopause. When testosterone levels are boosted back to normal levels, a woman`s desire for sex also returns to more normal levels.

Pfizer (PFE:NYSE - commentary - research) spent many years trying to prove that Viagra would also work for women, but while the drug did increase blood flow to the vagina (it does the same for a man`s penis), the drug giant found that women who took Viagra did not have an increased desire for sex. This bolstered the belief that hormones play a larger role in female sex drive and forced Pfizer earlier this year to stop testing Viagra for women.

Competitor`s Success Bolsters LibiGel
The best evidence of LibiGel`s efficacy, so far, actually comes from a larger competitor. Procter & Gamble (PG:NYSE - commentary - research) is developing Intrinsa, a testosterone patch that treats female sexual dysfunction. In May, the company announced positive results from a pivotal phase III study of 562 women, who had had their ovaries removed and were therefore in menopause. Women in the study who wore the testosterone patch reported a 74% increase in the frequency of satisfying sexual activity as well as a 56% increase in sexual desire vs. baseline. Results from the study were statistically significant, and Procter & Gamble is expected to seek Intrinsa marketing approval from the Food and Drug Administration by the end of the year.

BioSante is currently conducting a rigorous phase II study of LibiGel in a similar patient population. Late last year, the company announced positive interim results from this study. A final analysis is expected to be made public soon, possibly by the end of September. If this LibiGel study is positive, as expected, BioSante will move quickly to begin a pivotal phase III study in early 2005. If the phase III study is positive, BioSante could file for LibiGel approval by the end of 2006.

Having a marketing giant like Procter & Gamble ahead of it in this new product category is actually an advantage for BioSante. There are no treatments currently approved specifically for the use of testosterone therapy to treat female sexual dysfunction (some doctors prescribe male testosterone hormone treatments for women, but these have to be adjusted).




This means Procter & Gamble will need to make a large marketing investment, mainly through consumer advertising, to make women aware of the condition and introduce Intrinsa. This effort will be similar in scope to what Pfizer had to do when it launched Viagra. Who better to handle this task than a consumer products giant like Proctor & Gamble? Once LibiGel is approved, BioSante will be able to glide easily into the market created by Intrinsa.


Preferred Method Helps Market Outlook
Since female sexual dysfunction is a brand-new category, it`s hard to estimate the market size with complete accuracy. But scientific studies indicate that more than 40% of women experience some degree of sexual dysfunction. Analysts peg the total commercial market opportunity for products like Intrinsa and LibiGel at between $1 billion and $2 billion.

No one expects BioSante to grab majority market share from a marketing juggernaut like Procter & Gamble, but even a 10% to 20% slice of the total market will be a huge boon for the company, particularly given its current market cap. There are other companies developing similar products, including Cellegy Pharmaceuticals (CLGY:Nasdaq - commentary - research).

And there are some reasons to think that women might prefer LibiGel over Intrinsa. LibiGel is a clear gel applied to a small area of the skin once per day; Intrinsa is a patch that must be worn continuously and changed every three days. Once a women rubs LibiGel into her skin, it disappears without any residue and the testosterone is absorbed over 24 hours; patches like Intrinsa can cause skin irritation and could fall off.


LibiGel might be the brightest light in BioSante`s drug pipeline, but it`s not there by itself. The company is developing five other male and female hormone treatment products, including Bio-T-Gel, a male testosterone therapy that is expected to be marketed by Teva Pharmaceuticals (TEVA:Nasdaq - commentary - research) in exchange for royalty payments. For women, BioSante is also in late-stage clinical trials with Bio-E-Gel estrogen therapy.

[Indie.Jana]

es scheint, als wäre Biosante mit hohem Umsatz am langjährigen massiven Widerstand der 10Dollar gescheitert,

kurioserweise wurde dies alles unterstützt durch Verkaufsempfehlungen, FDA-Hinhaltetaktik usw....

Ein Schelm wer Böses dabei denkt

Jana

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



Biosante Pharmaceuticals Inc (BPA)

Headlines Get Headlines for:




Today, Fri, Dec 3, 2004
• [external] BioSante plunges on setback for P&G`s libido drug
Fri, Dec 3 - 2:55pm ET - at CBS MarketWatch
• [external] Sex Patch Returns to Lab
Fri, Dec 3 - 12:40pm ET - at Motley Fool
• BioSante Shares Drop on FDA Decision
Fri, Dec 3 - 11:18am ET - Associated Press
• Biosante downgraded by Caris & Company
Fri, Dec 3 - 10:19am ET - Briefing.com
• BioSante Pharmaceuticals Comments on FDA Advisory Committee`s Decision Not to Recommend Approval of Testosterone Patch
Fri, Dec 3 - 9:39am ET - PR Newswire
• [external] BioSante Punished After Intrinsa Vote
Fri, Dec 3 - 7:18am ET - TheStreet.com
Thu, Dec 2, 2004
• [external] UPDATE - Female sex-drive patch needs more study--US panel
Thu, Dec 2 - 7:07pm ET - at Reuters
• [external] FDA Panel Rejects Sex Drive Patch
Thu, Dec 2 - 5:35pm ET - at Forbes.com
• [external] FDA Seeks More Safety Data on Intrinsa
Thu, Dec 2 - 5:21pm ET - TheStreet.com
• [external] P&G sex-drive patch needs more study--US panel
Thu, Dec 2 - 4:20pm ET - at Reuters
Wed, Dec 1, 2004
• [external] FDA Looks at P&G`s Sex-Drive Drug
Wed, Dec 1 - 1:22pm ET - TheStreet.com
• FDA Questions P&G Female Sex-Drive Patch
Wed, Dec 1 - 1:09pm ET - Reuters
Tue, Nov 30, 2004
• [external] P&G Gambles on Intrinsa
Tue, Nov 30 - 10:56am ET - TheStreet.com
Mon, Nov 29, 2004
• BioSante Pharmaceuticals Announces Expansion of Patent Portfolio for CAP Nanotechnology with New European Patent
Mon, Nov 29 - 8:00am ET - Business Wire
Sat, Nov 20, 2004
• BioSante Pharmaceuticals, Financials
Sat, Nov 20 - 9:00am ET - EDGAR Online Financials
Mon, Nov 15, 2004
• BIOSANTE PHARMACEUTICALS INC Files SEC form 10QSB, Quarterly Report
Mon, Nov 15 - 2:37pm ET - EDGAR Online
• BioSante Pharmaceuticals to Present At NYSSA Healthcare Industry Conference
Mon, Nov 15 - 9:00am ET - Business Wire
Fri, Nov 12, 2004
• BIOSANTE PHARMACEUTICALS INC Files SEC form 8-K, Results of Operations, Financial Statements and Exhibits
Fri, Nov 12 - 11:33am ET - EDGAR Online
• BioSante Pharmaceuticals Announces Third Quarter Financial Results
Fri, Nov 12 - 10:18am ET - Business Wire
Mon, Nov 8, 2004
• BioSante Pharmaceuticals Presents Study Results For Transmucosal Insulin Administration
Mon, Nov 8 - 9:00am ET - Business Wire
Older Headlines - Download Recent Headlines
View headlines from: Mon, Nov 8, 2004Mon, Nov 1, 2004Mon, Oct 25, 2004Mon, Oct 18, 2004Mon, Oct 11, 2004Mon, Oct 4, 2004Mon, Sep 27, 2004Mon, Sep 20, 2004Mon, Sep 13, 2004Mon, Sep 6, 2004
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www.yahoo.com

[cristrader]

02.12.2004 22:34:
FDA-Gremium verwirft P&Gs Intrinsa

Ein der FDA vorgeschaltetes Fachgremium hat heute der Arzneimittelbehörde empfohlen, Procter & Gambles Testosteron-Pflaster Intrinsa nicht zuzulassen. Intrinsa war konzipiert worden, um den Sexualtrieb von Frauen zu stimulieren, denen die Ovarien entfernt worden sind. Offensichtlich war auch eine spätere Ausweitung der Indikation auf Frauen jenseits der Wechseljahre angedacht.

Das Gremium verlieh seiner Überzeugung Ausdruck, dass Intrinsa tatsächlich das sexuelle Erleben verstärken könne. Allerdings wurden die zwei sechsmonatigen Testphasen einhellig als zu kurz gewertet, um eventuelle Sicherheitsrisiken ausschließen zu können. Auch waren die Mediziner der Meinung, dass weitere Studien nötig seien, um mögliche Zusammenhänge mit Herzkrankheiten und Brustkrebs ausschließen zu können.


http://www.thestreet.com/_tsclsii/comment/adamfeuerstein/101…
BioSante Punished After Intrinsa Vote

By Adam Feuerstein
Senior Writer
12/3/2004 7:18 AM EST
Click here for more stories by Adam Feuerstein


BioSante Pharmaceuticals (BPA:AMEX - news - research) is wounded, maybe seriously.

The Thursday night rejection of Procter & Gamble`s (PG:NYSE - news - research) female testosterone sex-drive patch Intrinsa by a Food and Drug Administration advisory panel will almost certainly delay efforts by BioSante to develop its own product, a testosterone gel called LibiGel.

BioSante shares, trading in the green all day Thursday, plunged at the closing bell as the Intrinsa panel`s vote was taken. The stock closed the day down 90 cents, or 10%, to $7.50, then fell another $3.15, or 42%, to $4.35 in the after-hours session. Needless to say, this selloff is not what BioSante bulls (and I include myself in that category) were hoping for.

The FDA panel dinged Intrinsa over a lack of long-term safety data. Sharing concerns expressed by the FDA on Wednesday, the panel members were concerned that long-term use of testosterone by post-menopausal women already taking estrogen hormone therapy would raise their risk of heart attacks and cancer. A proposal by Proctor & Gamble to collect additional post-approval safety data from women using Intrinsa was dismissed by the panel as inadequate.

Although the FDA has yet to issue an approval decision on Intrinsa, the agency will likely follow the panel`s recommendation and ask Proctor & Gamble to collect additional safety studies before approval. But how much safety data need to be collected, and from how many patients? Will ongoing Intrinsa studies be sufficient, or will the company be forced to start new studies?

The answers to these questions are unclear, which has both good and bad implications for BioSante. The company was expected to begin a phase III study of LibiGel in the first quarter 2005. There will be a delay but BioSante CEO Stephen Simes, reached last night while he was boarding a plane leaving the Intrinsa panel meeting, is hopeful that it won`t last too long.



BioSante Punished After Intrinsa Vote
Page 2



"The FDA clearly wants to see more safety data, but the good news for us is that we are still designing our phase III trials, so we can include the recommendations of the [Intrinsa] panel into our protocol," says Simes. He adds that any delay in the start of the LibiGel phase III studies will be measured in months, not years.

Could this be wishful thinking? Certainly. One of the panel members reviewing Intrinsa`s safety, Dr. Steven Nissen, a cardiologist at Cleveland Clinic, suggested that adequate safety data would only come after studying Intrinsa`s use in thousands of women, maybe tens of thousands of women. These are hugely expensive and time-consuming studies typically required for drugs like cholesterol-lowering statins.

The FDA has been stung by sharp criticism that it is too lax on drug safety, especially following Merck`s (MRK:NYSE - news - research) withdrawal of Vioxx from the market. So, it`s not out of the realm of possibility to see the agency take a hard line with Proctor & Gamble about Intrinsa safety data.

Bottom line: Until Proctor & Gamble meets with the FDA to hammer out the exact safety requirements for Intrinsa, BioSante`s plans for LibiGel will also be on hold. And even if BioSante manages to get its phase III studies started relatively soon, the added burden of collecting more safety data could stretch out completion of the trials for many more months, if not years.

Simes says he`s hopeful that BioSante will be able to piggyback on any safety data collected by Proctor & Gamble -- and make BioSante`s task less onerous -- because testosterone, whether it enters the bloodstream via a patch (with Intrinsa) or through a gel application (with LibiGel), will have the same effect on a woman`s body.

To date, BioSante has been determined to develop LibiGel on its own, in order to maximize the potential for the product to its shareholders. But Thursday`s setback could force the company to raise more money to pay for larger, lengthier studies, or partner LibiGel with a larger company at less ideal terms.

It needs to be noted that BioSante is not a one-trick pony. The company does have other hormone therapy products in development, including an estrogen gel for women. Bio-E-Gel is wrapping up a pivotal phase III study and should be filed with the FDA in the middle of 2005. Unlike LibiGel, Bio-E-Gel shouldn`t run into unexpected regulatory delays because similar products are already on the market.

Please note that due to factors including low market capitalization and/or insufficient public float, we consider BioSante Pharmaceuticals to be a small-cap stock. You should be aware that such stocks are subject to more risk than stocks of larger companies, including greater volatility, lower liquidity and less publicly available information, and that postings such as this one can have an effect on their stock prices.


cristrader

[Bienenvater]

macht mich nachdenklich, im Hinblick auf das alten Thema "Gleichberechtigung":
Männer dürfen Viagra schlucken, - auch nicht risikofrei.
Frauen dürfen etwas in diese Richtung gehendes NICHT.
Sicher bestand das Gremium nur aus Männern.

PS: Bienenvater ist nicht weiblich.

[derschweizer]

@Cristrader, BrauchGeld, Neoe

Hallo Männers,

ich benötige dringend eure Meinung zu BioSante.
Wie wertet ihr den Absturz und was haltet ihr generell von einem jetzigen Einstieg in die Aktie.
Was spricht dafür, was dagegen?
Beobachte BioSante schon geraume Zeit und überlege heftig mir einige Aktien ins Depot zu legen.

Nikolausgrüße

derschweizer

[cristrader]

Hallo derschweizer!

Ich habe Biosante im letzten Winter bei Kursen um 3,60 $ verkauft. Damals war das Handelsvolumen zu gering. Seitdem verfolge ich den Kursverlauf von BPA mit einem weinenden Auge.

Man sollte trotz dem heutigen Anstieg erst einmal eine Bodenbildung abwarten. Eine genaue Abschätzung der Bewertung kann ich zurzeit nicht machen dazu habe ich mich nicht intensiv genug mit Biosante beschäftigt. Als Vorsichtsmassnahme würde ich Libigel aber als gescheitert betrachten. Die Aussichten und Kosten der weiteren Versuche sind zurzeit nicht abzuschätzen. Nach dem Vioxx/Merck-Debakel sind bei der FDA zudem wesentlich strengere Zulassungskriterien zu erwarten.

Wieviel ist der Rest der vielversprechenden Pipeline Wert?


Grüße cristrader

[derschweizer]

Hi cristrader,

danke für deine Einschätzung. Werde BioSante weiter beobachten und noch abwarten.

derschweizer

[MrRipley]

ich brauche mal ganz dringend ein paar Infos über, von und zur AMEX

Was ist die AMEX, wo ist die AMEX, wie handelt man an der AMEX wenn ein Wert dort gelistet ist,
ich aber bspw. bei Consors diesen Börsenplatz nirgends finden kann?


Bitte

R.R.

[MrRipley]

Sacht mir bloooß nicht, dass das nur ein BiotechIndex o.ä. ist

Blind wie ich bin, auch ich weiss nicht alles

[derschweizer]

@MrRipley

Nicht verwechseln mit der ASE

schönen Abend

derschweizer

[MrRipley]

ja watt denn nu?

[Kardoss]

13.12.2004
Nach der „ dreistufigen „ Korrektur wurde Biosante als „ spekulativ kaufen „ eingestuft.
Das Potential nach oben liegt im 12/04 bei ca. 6-7 USD.

Die Testphase III wird im I/IV/05 höchstwahrscheinlich mit Erfolg abgeschlossen
und die notwendigsten Sicherheitsbeweise an die FDA weitergeleitet.
Biosante hat ähnliche Delivery –Technologie wie Flamel..

[Indie.Jana]

[Indie.Jana]

Das richt förmlich nach einem "AKI" -Ausbruch