Halozyme---200-300% Chance - 500 Beiträge pro Seite

[BrauchGeld]

Hallo

Halozyme Therapeutics --- Amex:Hti
Kurs:1,77$
Marktkap:87 mio$


Erstes produkt (Enhanze SC) wird nach angaben ende 3.Q 05 zugelassen ca.400 mio$ markt für Enhanze SC.


Halozyme Therapeutics Receives FDA Priority Review for Enhanze SC NDA
Wednesday April 6, 8:00 am ET


SAN DIEGO, April 6 /PRNewswire-FirstCall/ -- Halozyme Therapeutics, Inc. (Amex: HTI - News), a development stage biopharmaceutical company focused on the development and commercialization of recombinant human enzymes, today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review status for Halozyme`s New Drug Application (NDA) for Enhanze SC(TM), pending the FDA`s formal acceptance of the application filing.
ADVERTISEMENT


Priority Review designation is granted by the FDA to products that are considered to be a potential therapeutic advance over current treatments and provides for a six-month review period, beginning with the date of the NDA submission. Halozyme submitted the Enhanze SC NDA on March 23, 2005, seeking approval for use of Enhanze SC as a spreading agent to facilitate the dispersion and absorption of other drugs.

"We are gratified that the FDA has responded so promptly in granting Priority Review status to Enhanze SC, in recognition of the potential benefits of the improved profile of recombinant human hyaluronidase compared to existing bovine and ovine alternatives in ophthalmology and drug delivery applications," said Jonathan Lim, MD, Halozyme`s Chairman and CEO. "Given the rapid review provision for products with Priority Review status, it is possible the FDA could complete its review by the end of the third quarter of this year."

According to the Food and Drug Administration Modernization Act (FDAMA), "Reviews for New Drug Applications are designated as either Standard or Priority. A Standard designation sets the target date for completing all aspects of a review and the FDA taking an action on the application at ten months after the date it was filed. A Priority designation sets the target date for the FDA action at six months."

Halozyme`s hyaluronidase (rHuPH20) is a recombinant form of the naturally occurring human enzyme and is being investigated for its ability to break down hyaluronic acid (HA), the space-filling "gel"-like substance that is a major component of tissues throughout the body. Hyaluronidase that is injected in the skin or in the muscle can temporarily digest the HA gel to enhance the penetration and diffusion of other injected drugs or fluids.

[BrauchGeld]

Halozyme Therapeutics and Baxter Healthcare Corporation Expand Relationship to Include Development and Supply Agreement
Wednesday March 30, 4:15 pm ET


SAN DIEGO and DEERFIELD, Ill., March 30 /PRNewswire-FirstCall/ -- Halozyme Therapeutics, Inc. (Amex: HTI - News), a development stage biopharmaceutical company focused on the development and commercialization of recombinant human enzymes, and Baxter Healthcare Corporation announced today that they have expanded their relationship by signing a development and supply agreement for Enhanze SC(TM), Halozyme`s recombinant human hyaluronidase enzyme (rHuPH20).
ADVERTISEMENT


In August 2004, Halozyme Therapeutics and Baxter Healthcare Corporation signed an exclusive sales and marketing agreement, under which Baxter and Halozyme are equal partners in the commercialization of Enhanze SC(TM), upon Food and Drug Administration (FDA) approval. Upon approval of the therapeutic by the FDA, Baxter will fill and finish Enhanze SC(TM) as well as market, distribute, and sell it in the United States and Puerto Rico. Under terms of the agreement, Halozyme also will grant Baxter a right of first refusal for additional select developmental stage products and territories.

Enhanze SC(TM), the first product in Halozyme`s Enhanze(TM) Technology portfolio, is a formulation of recombinant human hyaluronidase under development for use as a spreading agent to enhance the delivery of local anesthesia, contrast agents, and for subcutaneous fluid replacement (also called hypodermoclysis). Halozyme filed a New Drug Application (NDA) for Enhanze SC(TM) on March 23, 2005.

"This development and supply agreement builds upon our existing distribution agreement, and further solidifies our partnership with Baxter," said Jonathan Lim, MD, Halozyme`s Chairman and CEO. "Enhanze SC(TM) is an important product in our pipeline, and Baxter is an ideal partner to help us commercialize it."

"This agreement is a logical extension of our current distribution relationship with Halozyme," said Daniel Tasse, general manager for Baxter`s Anesthesia, Critical Care and Oncology business. "We will be able to provide enhanced value to customers by leveraging our manufacturing infrastructure, as well as our strong marketing channel in the Anesthesia and Critical Care market place."

Halozyme`s hyaluronidase (rHuPH20) is a recombinant form of the naturally occurring human enzyme and is being investigated for its ability to break down hyaluronic acid (HA), the space-filling gel-like substance that is a major component of tissues throughout the body. Hyaluronidase that is injected in the skin or in the muscle is being studied to determine if it can temporarily digest the HA gel to enhance the penetration and diffusion of other injected drugs or fluids.

[BrauchGeld]

www.halozyme.com

http://www.halozyme.com/3_0_products.htm

[BrauchGeld]

Ist auch hier zulande gelistet.

Cash:16 mio$

24-Mar-05 LIM, JONATHAN E.
Chief Executive Officer 100,000 Option Exercise at $0.39 per share. $39,000
9-Feb-05 RYNARD, CAROLYN
Vice President 100,000 Option Exercise at $0.39 per share. $39,000
14-Jan-05 RAMSAY, DAVID A
Chief Financial Officer 100,000 Option Exercise at $0.39 per share. $39,000
10-Jan-05 FROST, GREGORY IAN
Vice President 100,000 Option Exercise at $0.43 per share. $43,000
19-Aug-04 RAMSAY, DAVID A
Chief Financial Officer 10,000 Purchase at $1.62 per share. $16,200
18-Aug-04 FROST, GREGORY IAN
Vice President 5,000 Purchase at $1.65 per share. $8,250
18-Aug-04 LIM, JONATHAN E.
Chief Executive Officer 5,000 Purchase at $1.61 per share. $8,050
18-Aug-04 RAMSAY, DAVID A
Chief Financial Officer 10,000 Purchase at $1.60 per share. $16,000
18-Aug-04 ENGLER, ROBERT L MD
Director 10,000 Purchase at $1.60 per share. $16,000
11-Mar-04 WILSON, MARK
Vice President 50,000 Statement of Ownership N/A
11-Mar-04 RYNARD, CAROLYN
Vice President N/A Statement of Ownership N/A
11-Mar-04 RAMSAY, DAVID A
Chief Financial Officer 256,410 Statement of Ownership N/A
11-Mar-04 LIM, JONATHAN E.
Chief Executive Officer 484,497 Statement of Ownership N/A
11-Mar-04 KENNARD, DON A
Vice President N/A Statement of Ownership N/A
11-Mar-04 FROST, GREGORY IAN
Director 190,072 Statement of Ownership N/A
11-Mar-04 FROST, GREGORY IAN
Director 2,953,779 Statement of Ownership N/A
11-Mar-04 PATTON, JOHN STUART
Director 232,830 Statement of Ownership N/A
11-Mar-04 PATTON, JOHN STUART
Director 83,051 Statement of Ownership N/A
11-Mar-04 LECHNER, IRA M.
Director 693,745 Statement of Ownership N/A
11-Mar-04 LECHNER, IRA M.
Director 11,465 Statement of Ownership N/A
11-Mar-04 LECHNER, IRA M.
Director 190,072 Statement of Ownership N/A
11-Mar-04 LECHNER, IRA M.
Director 100,000 Statement of Ownership N/A
11-Mar-04 MERCALDO, EDWARD L.
Director 123,883 Statement of Ownership N/A
11-Mar-04 MERCALDO, EDWARD L.
Director 480,145 Statement of Ownership N/A
11-Mar-04 MERCALDO, EDWARD L.
Director 116,415 Statement of Ownership N/A

[BrauchGeld]

Halozyme Therapeutics Adds Vice President of Clinical Development and Medical Affairs to Management Team
Tuesday April 12, 8:00 am ET


SAN DIEGO, April 12 /PRNewswire-FirstCall/ -- Halozyme Therapeutics, Inc. (Amex: HTI - News), a development stage biopharmaceutical company focused on the development and commercialization of recombinant human enzymes, today announced that Richard C. Yocum, MD, has joined the company as Vice President of Clinical Development and Medical Affairs. Dr. Yocum brings to Halozyme over 23 years of experience in clinical drug development, project team management, clinical research trial design and implementation, and patient care, according to Jonathan Lim, MD, Halozyme`s Chairman and CEO.
ADVERTISEMENT


"We are thrilled to have Richard join Halozyme," said Dr. Lim. "His experience spans all phases of clinical development, including New Drug Application (NDA) preparations and submissions leading to multiple product approvals, which will be invaluable as we continue to develop our product candidates across multiple therapeutic areas. Richard`s expertise and track record of successfully developing oncology drugs will become especially salient as our team develops Chemophase(TM) for the treatment of solid tumors and seeks to initiate a clinical trial in the second half of this year."

Prior to joining Halozyme, Dr. Yocum was Vice President of Clinical Development and Medical Affairs at Chugai Pharma USA, LLC (CPUSA), a member of the Chugai-Roche group. From 1995 to 2002, Dr. Yocum was responsible for the clinical development of several retinoid-based drugs for the treatment of various cancers and benign dermatological diseases at Ligand Pharmaceuticals, where he was involved in the approval of seven of seven new drug registration dossiers, and served most recently as Executive Medical Director of Clinical Development. From 1993 to 1995, Dr. Yocum was employed in the Clinical Research department at Gensia. Dr. Yocum is board-certified in general internal medicine, and maintained a clinical practice for nine years before transitioning to the pharmaceutical industry. He received his AB in Chemistry from Dartmouth College, his MD from Johns Hopkins University, and completed his medical residency at the University of California, San Diego.

[BrauchGeld]

Hallo

Halozyme Therapeutics Announces rHuPH20 Hyaluronidase Preclinical Data Presented at the 2005 American Society of Cataract & Refractory Surgery Symposium and Congress
Monday April 18, 4:12 pm ET
- rHuPH20 Enzyme Significantly Reduces the Incidence and Severity of Intraocular Pressure Rises


WASHINGTON, April 18 /PRNewswire-FirstCall/ -- Halozyme Therapeutics, Inc. (Amex: HTI - News), a development stage biopharmaceutical company focused on the development and commercialization of recombinant human enzymes, announced today that results from new preclinical studies with Halozyme`s recombinant human PH20 (rHuPH20) hyaluronidase enzyme were presented earlier today at the 2005 American Society of Cataract & Refractive Surgery (ASCRS) Symposium on Cataract, IOL and Refractive Surgery, American Society of Ophthalmic Administrators (ASOA) Congress on Ophthalmic Practice Management, and the Clinical and Surgical Staff Program in Washington, D.C. The data were presented at the ASCRS Innovators Session by Herbert E. Kaufman, MD, Boyd Professor of Ophthalmology and Pharmacology & Experimental Therapeutics at the Louisiana State University Health Sciences Center School of Medicine in New Orleans.
ADVERTISEMENT


Dr. Kaufman presented preclinical safety and pharmacology animal studies demonstrating that when viscoelastic agents commonly used in cataract surgery were placed in the eyes of animals, injection of Halozyme`s rHuPH20 enzyme into the front of the eye significantly reduced the incidence and severity of intraocular pressure (IOP) rises. Such pressure "spikes" are believed to occur when viscoelastic materials used in the surgical procedure clog up the eye`s drainage canals and prevent fluid from properly draining out of the eye, a process that can potentially result in permanently dilated pupils, persistent glare, pain, and discomfort, and retinal and optic nerve vascular occlusion. Dr. Kaufman`s data also showed that injection of rHuPH20 into the front of the eye caused no toxicity to the corneal endothelial cells in the eye.

"These findings further support an innovative new application of the rHuPH20 enzyme and warrant further investigation," said Gregory Frost, PhD, Halozyme`s Vice President and Chief Scientific Officer. "Minimizing surgical complications from cataract surgery could be helpful for a large number of patients, given that more than 13 million cataract surgeries are performed worldwide every year."

Halozyme`s hyaluronidase (rHuPH20) is a highly purified, recombinant form of the naturally occurring human enzyme and is being investigated for its ability to break down hyaluronic acid (HA), the space-filling "gel"-like substance that is a major component of tissues throughout the body. The rHuPH20 enzyme can degrade most viscoelastic agents used in clinical practice and therefore could potentially be developed for use as a viscoelastic "antidote" in patients undergoing cataract surgery, in which viscoelastic agents are used in every case to prevent damage to the cornea.

[BrauchGeld]

Halozyme Therapeutics Receives FDA 510(k) Clearance for Cumulase
Tuesday April 19, 8:00 am ET


SAN DIEGO, April 19 /PRNewswire-FirstCall/ -- Halozyme Therapeutics, Inc. (Amex: HTI - News), a development stage biopharmaceutical company focused on the development and commercialization of recombinant human enzymes, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Cumulase(TM) for the treatment of oocytes to facilitate certain in vitro fertilization (IVF) procedures. The active pharmaceutical ingredient in Cumulase is the first and only recombinant human hyaluronidase approved in the United States for cumulus removal in the IVF process.
"We are thrilled to receive FDA 510(k) clearance to market our first product in the U.S.," said Jonathan Lim, MD, Halozyme`s Chairman and CEO. "This achievement is a key milestone for our company and provides validation of our technology and our team`s ability to develop and commercialize products based on recombinant human hyaluronidase."

Cumulase is an ex vivo formulation of rHuPH20 (recombinant human PH20 hyaluronidase) to replace bovine and ovine extracts currently used for the preparation of oocytes prior to IVF during the process of intracytoplasmic sperm injection (ICSI), in which the enzyme is an essential component. The enzyme strips away the hyaluronic acid that surrounds the oocyte, allowing the clinician to then perform ICSI, injecting the sperm into the oocyte. Cumulase provides the IVF specialist with a safer, purer and more reliable alternative to slaughterhouse-derived extracts.

The total Cumulase market consists of an estimated 500,000 ICSI cycles worldwide in 2005, with nearly 90,000 of those performed in the U.S. Halozyme received CE Mark approval of Cumulase in late 2004 to market the product throughout the EU. The company has signed agreements with Cook Ob/Gyn Incorporated, MediCult A/S, and MidAtlantic Diagnostics, Inc., to distribute Cumulase worldwide. In February, Halozyme signed a commercial manufacturing supply agreement with Avid Bioservices to manufacture the recombinant human enzyme under current good manufacturing practices (cGMPs).

[BrauchGeld]

Halozyme Therapeutics` Enhanze Technology Featured in Drug Delivery Technology
Wednesday May 4, 12:46 pm ET


SAN DIEGO, May 4 /PRNewswire-FirstCall/ -- Halozyme Therapeutics, Inc. (Amex: HTI - News), a development stage biopharmaceutical company focused on the development and commercialization of recombinant human enzymes, today announced the publication of "Escaping the Matrix With Enzyme-Mediated Delivery" in the May issue of Drug Delivery Technology. The cover article highlights Halozyme`s Enhanze(TM) Technology, an enzyme-based drug delivery platform based on recombinant human PH20 (rHuPH20) hyaluronidase. Applications of Enhanze Technology to deliver locally injected drugs are presented in preclinical pharmacokinetic models. The interstitial matrix is a significant barrier to the effective delivery of molecules by subcutaneous, intradermal, and intramuscular routes of administration; Enhanze Technology is being developed to overcome this barrier to allow conversion of intravenously injected drugs to these potentially more convenient local routes of administration.
The rHuPH20 enzyme breaks down hyaluronic acid (HA), the space-filling "gel"-like substance that is a major component of tissues throughout the body, potentially permitting administration of up to five times more volume than normally feasible for subcutaneously injected drugs, e.g., 5-10 mL vs. 1-2 mL, respectively. This effect, also observed with large molecules such as therapeutic monoclonal antibodies that must be given intravenously today, is accompanied by faster time to peak serum concentrations, and significantly increased drug levels in the bloodstream, similar to what is observed in intravenous administration. This may permit conversion of intravenously- administered pharmaceuticals to more desirable local routes, and may even permit patients to self-administer select chronic injectable medicines, reducing the need for hospital visits. The article can be found at www.drugdeliverytech.com.

[BrauchGeld]

Halozyme Therapeutics Reports First Quarter 2005 Financial Results
Friday May 13, 8:00 am ET
- Conference Call and Webcast to Be Held Today at 7:00 AM PDT -


SAN DIEGO, May 13 /PRNewswire-FirstCall/ -- Halozyme Therapeutics, Inc. (Amex: HTI - News), a development stage biopharmaceutical company focused on the development and commercialization of recombinant human enzymes, today reported progress and financial results for the quarter ended March 31, 2005.

First Quarter 2005 and Subsequent Highlights

* Filing a New Drug Application (NDA) with the U.S. Food and Drug
Administration (FDA) on March 23 for Hylenex(TM) (formerly referred to
as Enhanze SC(TM)), the first product in Halozyme`s Enhanze(TM)
Technology portfolio, for potential use as a "spreading agent" to
enhance the drug delivery of local anesthesia, contrast agents, and
for subcutaneous fluid replacement (also called hypodermoclysis). The
application was subsequently granted FDA Priority Review status,
pending the formal acceptance of the filing.

* Expanding Baxter Healthcare`s and Halozyme`s relationship by signing a
development and supply agreement for Hylenex. Subject to approval of
the therapeutic by the FDA, Baxter will fill and finish Hylenex as
well as market, distribute, and sell it in the U.S. and Puerto Rico.
Under terms of the agreement, Halozyme also will grant Baxter a right
of first refusal for additional select developmental stage products
and territories.

* Receiving 510(k) clearance from the FDA for Cumulase(TM) for the
treatment of oocytes to facilitate certain in vitro fertilization
(IVF) procedures. Cumulase is the first and only recombinant human
hyaluronidase product approved in the United States for cumulus
removal in the IVF process.

* Presenting results from new preclinical studies investigating the use
of Halozyme`s rHuPH20 hyaluronidase enzyme in conjunction with
chemotherapy at the American Association for Cancer Research in
Anaheim, California. Studies conducted in collaboration with the
University of Trondheim, Norway, showed that rHuPH20 reduced both
tumor interstitial fluid pressure in animal models and the resistance
of cultured human bladder carcinoma aggregates to a commonly used
chemotherapy agent. The company also announced its selection of
bladder cancer as its first therapeutic target for Chemophase(TM) in
oncology.

* Presenting results from new preclinical studies with Halozyme`s
rHuPH20 hyaluronidase enzyme at the 2005 Association for Research in
Vision and Ophthalmology annual meeting in Fort Lauderdale, Florida.
Preclinical safety and pharmacology animal studies conducted with
Halozyme`s rHuPH20 hyaluronidase enzyme showed that when viscoelastic
agents commonly used in cataract surgery were left in the eyes of
animals, injection of Halozyme`s rHuPH20 enzyme into the front of the
eye significantly reduced the incidence and severity of intraocular
pressure rises.

* Signing a commercial manufacturing supply agreement with Avid
Bioservices, Inc., under which Avid will manufacture under current
good manufacturing practices Halozyme`s first recombinant human enzyme
to be used in Cumulase and Hylenex.

* Bolstering the management team with the addition of Richard C. Yocum,
MD, who joined Halozyme as its new Vice President of Clinical
Development and Medical Affairs. Dr. Yocum brings to Halozyme over 23
years of experience in clinical drug development, project team
management, clinical research trial design and implementation, and
patient care.

First Quarter 2005 Financial Results

* Net loss for the first quarter of 2005 was $3.2 million, or $0.06 per
share, compared with a net loss for the first quarter of 2004 of
$1.3 million, or $0.08 per share.

* Research and development expenses for the first quarter of 2005 were
$2.5 million, compared with $0.7 million for the first quarter of
2004, reflecting increased research, development and manufacturing
expenses associated with the Company`s Cumulase and Hylenex product
candidates.

* General and administrative expenses for the first quarter of 2005 were
$0.8 million, compared with $0.5 million for the first quarter of
2004, reflecting increased personnel costs and the costs of being a
public company, including those to support compliance with the
internal control aspects of the Sarbanes-Oxley legislation.

* Cash and cash equivalents were $13.0 million as of March 31, 2005
compared with $16.0 million as of December 31, 2004 and $7.5 million
as of March 31, 2004.

"We continue to make solid progress on all fronts and are meeting our milestones, including FDA approval of our first product Cumulase, as targeted," stated Jonathan Lim, MD, Halozyme`s Chairman and CEO. "With the expansion of our agreement with Baxter and the signing of our commercial manufacturing agreement with Avid to produce our recombinant human enzyme for use in Cumulase and Hylenex, we believe Halozyme is well-positioned and well-capitalized to achieve our clinical and commercialization goals this year."

Dr. Lim continued, "We are also excited about potentially bringing Chemophase, Halozyme`s oncology drug candidate, into the clinic later this year. Chemophase is designed to enhance the delivery of chemotherapeutic agents to tumor tissue, which may renew response to chemotherapy regimens and potentially increase patient survival. Our goal is to initiate clinical trials in bladder cancer beginning in the second half of 2005."

Conference Call

Halozyme management will host an investment community conference call today to discuss these topics beginning at 7:00 a.m. PT (10:00 a.m. ET). To participate via telephone, please call 888-463-4487 for domestic callers, or 706-679-5355 for international callers. A telephone replay will be available for 48 hours by dialing 800-642-1687 from the U.S., or 706-645-9291 for international callers, and entering reservation number 6103423. The conference call will be broadcast live over the Internet at www.halozyme.com and will be available for 30 days.

[BrauchGeld]

Hallo

Halozyme Therapeutics Announces FDA Acceptance of Hylenex NDA
Thursday May 26, 12:28 pm ET


SAN DIEGO, May 26 /PRNewswire-FirstCall/ -- Halozyme Therapeutics, Inc. (Amex: HTI - News), a development stage biopharmaceutical company focused on the development and commercialization of recombinant human enzymes, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing and review Halozyme`s New Drug Application (NDA) for Hylenex(TM) (formerly referred to as Enhanze SC(TM)).
Halozyme submitted the Hylenex NDA on March 23, 2005, seeking approval for use as a spreading agent to facilitate the dispersion and absorption of other drugs. The Company previously announced in April 2005 that the FDA granted Priority Review status to the Hylenex NDA, which sets the target date for initial FDA action within six months from the NDA submission date.

"We are excited that the FDA has accepted our NDA filing," said Jonathan Lim, MD, Halozyme`s Chairman and CEO. "This is a significant step in the FDA`s review of Hylenex for use as a spreading agent. If approved by the FDA, we believe Hylenex could offer physicians an attractive alternative to animal-derived hyaluronidases."

Halozyme`s hyaluronidase (rHuPH20) is a highly purified, recombinant form of the naturally occurring human enzyme and is being investigated for its ability to break down hyaluronic acid (HA), the space-filling "gel"-like substance that is a major component of tissues throughout the body. Hyaluronidase that is injected in the skin or in the muscle can temporarily digest the HA gel to enhance the penetration and diffusion of other injected drugs or fluids.

[BrauchGeld]

Hallo

Halozyme steht kurz davor neue höhen zu erklimmen ,noch kann man günstig einsteigen.

Kurs:2,01$
Widerstand:~2,10$

27-May-05 RAMSAY, DAVID A
Chief Financial Officer 10,000 Direct Purchase at $1.98 - $2 per share. $20,0002
24-May-05 ENGLER, ROBERT L MD
Director 25,000 Direct Purchase at $1.93 - $1.99 per share. $49,0002

[BrauchGeld]

Halozyme Therapeutics Scheduled to Join the New Russell Microcap Index
Monday June 13, 12:41 pm ET


SAN DIEGO, June 13 /PRNewswire-FirstCall/ -- Halozyme Therapeutics (Amex: HTI - News), a biopharmaceutical company focused on the development and commercialization of recombinant human enzymes, announced today that it is scheduled to join the new Russell Microcap(TM) Index when the Russell Investment Group reconstitutes its family of U.S. indexes on June 24. Russell recently posted a preliminary membership list at: http://www.russell.com/us/indexes/us/reconstitution/microcap… .
The Russell Microcap Index will be comprised of the smallest 1,000 securities in the small-cap Russell 2000® Index plus the next 1,000 companies, based on a ranking of all U.S. equities by market capitalization. This new index offers managers and other investors a comprehensive, unbiased barometer to compare their performance against the genuine microcap marketplace of stocks.

"The inclusion in the Russell index is recognition from the investment community of the many milestones we have achieved this year," said Jonathan Lim, MD, Halozyme`s Chairman and CEO. "Recently, the FDA accepted for filing and review our New Drug Application for Hylenex(TM), the first product in Halozyme`s Enhanze(TM) Technology portfolio for potential use as a "spreading agent" to enhance the drug delivery of local anesthesia, contrast agents, and for subcutaneous fluid replacement. Also, we received 510(k) clearance from the FDA for Cumulase(TM) for the treatment of oocytes to facilitate certain in vitro fertilization (IVF) procedures. We also expanded our relationship with Baxter Healthcare for the development of Hylenex. We believe these, and other key events, position Halozyme well for the future."

The Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for both passive and active investment strategies. More than $2.5 trillion in assets currently are benchmarked to them. Investment managers who oversee these funds purchase shares of member stocks according to that company`s weighting in the particular index.

Companies slated for the Russell Microcap were ranked as of May 31 by total market capitalization and weighted based on free-float adjustment, an integral aspect of Russell index methodology. Free-float adjustment means stocks are weighted by their available market capitalization which is calculated by multiplying the primary closing price by the available shares

[BrauchGeld]

Halozyme Therapeutics Announces Launch of Cumulase for In Vitro Fertilization
Monday June 20, 8:00 am ET


SAN DIEGO, June 20 /PRNewswire-FirstCall/ -- Halozyme Therapeutics, Inc. (Amex: HTI - News), a development stage biopharmaceutical company focused on the development and commercialization of recombinant human enzymes, today announced the worldwide market launch of Cumulase(TM) for the treatment of oocytes to facilitate certain in vitro fertilization (IVF) procedures. The active pharmaceutical ingredient in Cumulase is the first and only recombinant human hyaluronidase approved in the United States and in the European Union (EU) for cumulus removal in the IVF process. Halozyme received 510(k) clearance from the U.S. Food and Drug Administration (FDA) in April 2005. Halozyme also received CE Mark approval of Cumulase in December 2004 to market the product throughout the EU.
"We are thrilled to launch our first product and to offer IVF specialists a safer, purer and more reliable alternative to animal-derived extracts," said Jonathan Lim, MD, Halozyme`s Chairman and CEO. "This achievement validates our team`s ability to develop and commercialize products based on recombinant human hyaluronidase. We will market Cumulase throughout the U.S. and the European Union, and in other select countries in Asia."

Cumulase is an ex vivo formulation of rHuPH20 (recombinant human PH20 hyaluronidase) to replace bovine and ovine extracts currently used for the preparation of oocytes prior to IVF during the process of intracytoplasmic sperm injection (ICSI), in which the enzyme is an essential component. The enzyme removes the hyaluronic acid that surrounds the oocyte, allowing the clinician to then perform ICSI, injecting the sperm into the oocyte. Cumulase provides the IVF specialist with a safer, purer and more reliable alternative to slaughterhouse-derived extracts.

The total Cumulase market consists of an estimated 500,000 ICSI cycles worldwide in 2005, with nearly 90,000 of those performed in the U.S. The company has signed agreements with MediCult A/S and MidAtlantic Diagnostics, Inc., to distribute Cumulase worldwide in 1X ready-to-use and 10X concentrate product presentations, respectively. In February, Halozyme signed a commercial manufacturing supply agreement with Avid Bioservices to manufacture the recombinant human enzyme under current good manufacturing practices (cGMPs).

[Bombenleger]

interessante firma

[BrauchGeld]

Hallo


Halozyme Therapeutics Announces Clinical Safety and Tolerability Data for rHuPH20 Hyaluronidase Presented at BIO 2005
Tuesday June 21, 4:15 pm ET


PHILADELPHIA, June 21 /PRNewswire-FirstCall/ -- Halozyme Therapeutics, Inc. (Amex: HTI - News), a development stage biopharmaceutical company focused on the development and commercialization of recombinant human enzymes, today announced results from a clinical trial showing the absence of allergic reactions to recombinant human hyaluronidase (rHuPH20) and significantly reduced injection site discomfort compared to the saline control. The data were presented today by Michael F. Haller, PhD, Senior Director of Corporate Development, at the Biotechnology Industry Organization (BIO) 2005 Conference in Philadelphia, Pennsylvania.
Dr. Haller presented the findings of the double-blinded clinical study comparing rHuPH20 to a saline control in 100 healthy human volunteers. These volunteers were injected intradermally with rHuPH20 in one forearm and saline control in the other forearm, and evaluated for allergic responses and injection site side effects. None (0) of the 100 subjects had evidence of allergenicity. With regard to side effects, 28 of the 100 subjects experienced discomfort (e.g., stinging, burning, other discomfort) at the site of saline injection, whereas significantly fewer, 3 of the 100 subjects, experienced such side effects at the site of rHuPH20 injection.

"These clinical data show that rHuPH20 is well-tolerated by healthy human volunteers," said Richard C. Yocum, MD, Halozyme`s Vice President of Clinical Development and Medical Affairs. "The lack of allergic response to rHuPH20 is important, as the most frequently reported adverse experiences with currently available, animal-derived hyaluronidase products are local injection site reactions. The significant reduction in injection site discomfort is consistent with the rapid-onset mechanism of action of this enzyme."

Halozyme`s rHuPH20 is a highly purified, recombinant form of the naturally occurring human enzyme and is being investigated for its ability to break down hyaluronan (HA, also known as hyaluronic acid), the space-filling "gel"-like substance that is a major component of tissues throughout the body. Hyaluronidase that is injected in the skin or in the muscle can temporarily digest the HA gel to enhance the penetration and diffusion of other injected drugs or fluids.

[BrauchGeld]

Hi

22.06.2005 19:24
Halozyme Therapeutics und Reproductive Biology Associates kündigen neue klinische Daten bei IVF an: Befruchtungsraten durch Cumulase deutlich gestiegen

KOPENHAGEN, Dänemark, June 22 (ots/PRNewswire) - Halozyme
Therapeutics, Inc. (Amex: HTI), ein Entwicklungs-
Biopharmaunternehmen mit Schwerpunkt auf der Entwicklung und
Kommerzialisierung rekombinanter menschlicher Enzyme, und
Reproductive Biology Associates, eines der führenden IVF-Zentren der
USA, gaben heute bekannt, dass in klinischen Studien gesteigerte
Befruchtungsraten von Oozyten (Eizellen), die vor der In Vitro
Fertilisation (IVF) durch intrazytoplasmatische Spermieninjektion
(ICSI) mit Cumulase (TM) behandelt wurden, nachgewiesen werden
konnten. Die Ergebnisse wurden heute von Z. Peter Nagy, M.D., Ph.D.,
Scientific and Laboratory Director bei Reproductive Biology
Associates in Atlanta, im US-Bundesstaat Georgia, bei der 21.
Jahresversammlung der European Society of Human Reproduction &
Embryology (ESHRE) in Kopenhagen vorgestellt.

Dr. Nagy präsentierte klinische Studien, in denen Cumulase mit
einem derzeit verwendeten, aus Tiergewebe gewonnenen
Hyaluronidase-Extrakt bei der Präparation menschlicher Oozyten für
das ICSI-Verfahren verglichen wurde. Die von Dr. Nagy bei
Reproductive Biology Associates durchgeführte Studie hat erwiesen,
dass bei den mit Cumulase behandelten Oozyten deutlich höhere
Befruchtungsraten erzielt werden konnten als bei Oozyten, die mit dem
Standard-Hyaluronidase-Extrakt aus Rindergewebe behandelt worden
waren. In der Studie wurden 26 Patienten und 402 Oozyten untersucht.
Die Befruchtungsrate nach der ICSI lag bei mit Cumulase behandelten
Eizellen bei 81,4% (162 von 199 Eizellen befruchtet) verglichen mit
71,9% (146 von 203 Eizellen befruchtet) bei den mit dem
herkömmlichen Rinderextrakt behandelten Eizellen - eine Steigerung
der Befruchtungsrate um 13%. Die durchschnittliche Erfolgsquote bei
ICSI liegt in den Fruchtbarkeitskliniken der USA derzeit bei 70 bis
75%.

"Diese Daten sind äusserst erfolgversprechend", berichtete Dr.
Nagy. "Neben den höheren Fruchtbarkeitsraten konnte bei Behandlung
mit Cumulase im Vergleich zu den Hyaluronidase-Extrakten aus
Rindergewebe auch eine bessere Qualität der Embryonen für den
Transfer festgestellt werden. Gesteigerte Befruchtungsraten zusammen
mit höherer Embryonenqualität für den Transfer sind äusserst
bedeutende Untersuchungsergebnisse für die IVF."

"Wir freuen uns sehr über diese Resultate", kommentierte Jonathan
Lim, MD, Vorsitzender und CEO von Halozyme. "Es wurde nicht nur eine
sicherere, zuverlässigere Alternative zu den Enzymen aus Tiergewebe
nachgewiesen. Die Daten ergaben ausserdem, dass durch den Einsatz
von Cumulase möglicherweise höhere Befruchtungsraten als durch die
bisherige Standardbehandlung erzielt werden können. Die Patienten
sind sich in der Regel nicht bewusst, dass bei der ICSI Material aus
Rinder- oder Schafgewebe verwendet wird. Mit Cumulase steht ihnen
unserer Ansicht nach - neben der Behandlung durch IVF-Experten eine
attraktive Alternative zur Verfügung."

Cumulase ist eine Ex-vivo-Rezeptur von rHuPH20 (rekombinante
menschliche PH20-Hyaluronidase), welche die derzeit im Vorfeld der
IVF verwendeten Rinder- und Schafsenzyme bei der Präparation von
Oozyten für die ICSI, bei der das Enzym eine tragende Rolle spielt,
ersetzen könnte. Das Enzym entfernt die Hyaluronsäure, von der die
Eizelle umgeben ist, und ermöglicht dem Arzt die ICSI durchzuführen,
d.h. das Spermium in die Oozyte zu spritzen. Mit Cumulase verfügt
der IVF-Spezialist über eine sicherere, reinere und wirkungsvollere
Alternative zu den Extrakten aus Tiergewebe.

Der Cumulase-Markt wird für 2005 auf weltweit insgesamt 500.000
ICSI- Zyklen geschätzt, von denen knapp 90.000 im Dezember 2004 bei
der Zulassung zur CE-Kennzeichnung für Halozyme in den USA
durchgeführt wurden, um das Produkt in der EU zu vermarkten. Im
April 2005 erhielt Halozyme die 510(k)- Freigabe der FDA für die
Vermarktung des Produkts in den Vereinigten Staaten. Cumulase ist
das erste und einzige rekombinante menschliche Hyaluronidase-
Produkt, das für die Kumulusentfernung bei der In Vitro Fertilisation
zugelassen wurde. Das Unternehmen hat Abkommen mit Cook Ob/Gyn
Incorporated, MediCult A/S und MidAtlantic Diagnostics, Inc. für den
weltweiten Vertrieb von Cumulase geschlossen.

Reproductive Biology Associates

Reproductive Biology Associates (RBA) (www.rba-online.com),
gegründet im Jahr 1982, stellt neuartige Reproduktionstechnologie
für Patienten her, bei denen durch konventionelle Diagnostik und
Therapien keine Schwangerschaft erzielt werden konnte. Seit seinen
Anfängen ist RBA führend in der Entwicklung und Verbesserung
klinischer Abläufe und wissenschaftlicher Techniken, mit denen die
Erfolge bei der Erzielung von Schwangerschaften erhöht werden. RBA
war 1988 das erste IVF-Programm der Welt, das als Erfolg ein Baby
präsentieren konnte, welches durch eine als Partielle Zona
Dissektion (PZD) bekannte Mikromanipulationstechnik entstanden war.
1993 wurde RBA zum ersten Zentrum der USA, das durch
intrazytoplasmatische Spermieninjektion (ICSI) eine Schwangerschaft
und die Geburt eines Babys erreichte. Im Anschluss daran konnte RBA
als erstes IVF-Zentrum der USA Erfolge bei der Spermienentnahme
durch die so genannte TESA-Prozedur (testicular sperm aspiration)
melden. RBA war das dritte IVF-Programm der Vereinigten Staaten,
durch das es gelang, eine Schwangerschaft mittels eines
tiefgefrorenen Embryos zu erzielen, und 1997 die erste Klinik der
westlichen Hemisphäre, durch die ein Baby mittels Kryokonservierung
von Oozyten geboren werden konnte. Im Jahr 2004 entwickelte RBA ein
neues Verfahren für intrauterine Insemination durch den so genannten
Platelet Activating Factor (PAF).

RBA erfreut sich einer grossen Präsenz in den weltweiten Medien,
unter anderem in Time, People, Newsweek, U.S. News & World Report,
The Wall Street Journal, The New York Times, Dateline NBC, 20/20,
Good Morning America, The Today Show, CNN, BBC und Hunderten anderen
Print- und Rundfunk-Medien.

Halozyme Therapeutics (Nachrichten).

Halozyme ist ein Entwicklungs-Biopharmaunternehmen mit Schwerpunkt
auf der Entwicklung und Vermarktung rekombinanter menschlicher
Enzyme in den Bereichen Unfruchtbarkeit, Ophthalmologie und
Onkologie. Die Bandbreite der in Entwicklung befindlichen Produkte
der Firma basiert auf den gewerblichen Schutz- und Urheberrechten an
der als Hyaluronidasen bekannten Familie menschlicher Enzyme. Die
rekombinanten menschlichen Enzyme von Halozyme werden möglicherweise
die derzeitigen, aus Tiergewebe gewonnenen Enzyme ersetzen, welche
potentielle Risiken einer Übertragung von Krankheitserregern und
Immunogenität bergen. Die Vielseitigkeit des ersteren Enzyms,
rHuPH20, versetzt Halozyme in die Lage, das Produkt als
medizinisches Hilfsmittel, medikamentenverbessernden Wirkstoff und
therapeutisches biologisches Präparat zu entwickeln.

[BrauchGeld]

Hallo

In September ist es soweit da wird hoffentlich das zweite produkt von Halozyme zugelassen.

Übernächste Woche gibts zahlen mal gespannt wieviel geld Halozyme durch cumulase verdient hat das seit letzten monat auf den Markt ist.

Halozyme Therapeutics to Hold Second Quarter 2005 Conference Call on August 8
Wednesday July 27, 4:15 pm ET


SAN DIEGO, July 27 /PRNewswire-FirstCall/ -- Halozyme Therapeutics, Inc. (Amex: HTI - News), a biopharmaceutical company focused on the development and commercialization of recombinant human enzymes, today announced that it will release second quarter 2005 results before the market opens on Monday, August 8, 2005.
Jonathan Lim, MD, Chairman and Chief Executive Officer, Gregory Frost, PhD, Vice President and Chief Scientific Officer, and David Ramsay, Vice President and Chief Financial Officer, will host an investment community conference call beginning at 8:00 a.m. PT (11:00 a.m. ET) on Monday, August 8, 2005, to discuss the results and provide a business update.

Individuals interested in participating in the conference call may do so by dialing 888-463-4487 for domestic callers, or 706-679-5355 for international callers. Those interested in listening to the conference call live via the Internet may do so by visiting the Investor Relations section of the Company`s website at www.halozyme.com. A replay will be available on Halozyme`s website for 30 days. A telephone replay will be available for 48 hours by dialing 800-642-1687 from the U.S., or 706-645-9291 for international callers, and entering reservation number 8211578.

[BrauchGeld]

Hallo

Halozyme und Baxter weiten ihre Partnerschaft aus.
Noch 5 wochen bis zur Zulassung.

Halozyme Therapeutics and Baxter Healthcare Corporation Expand Relationship to Include European Union
Monday August 8, 8:00 am ET


SAN DIEGO and DEERFIELD, Ill., Aug. 8 /PRNewswire-FirstCall/ -- Halozyme Therapeutics, Inc. (Amex: HTI - News), a biopharmaceutical company focused on the development and commercialization of recombinant human enzymes, and Baxter Healthcare Corporation (Baxter) announced today that Baxter has exercised its option to market, sell, and distribute Hylenex(TM) in the European Union. Hylenex is a local formulation of recombinant human hyaluronidase under development for use as a "spreading agent" to enhance the delivery of local anesthesia, contrast agents, and for subcutaneous fluid replacement (also called hypodermoclysis). Halozyme filed a New Drug Application in the United States for Hylenex on March 23, 2005 and will be filing for regulatory approval in the European Union.

In August 2004, Halozyme and Baxter first entered into an exclusive sales and marketing agreement under which Baxter and Halozyme are equal partners in the commercialization of Hylenex upon U.S. Food and Drug Administration (FDA) approval. Under the original terms of the agreement, Baxter will fill and finish Hylenex as well as market, distribute, and sell Hylenex in the United States and Puerto Rico. Halozyme also granted Baxter a right of first refusal for additional select developmental stage products and territories. The companies have now added the additional territory of the European Union to the partnership.

"Baxter`s decision to expand our partnership to include the European Union is a strong validation of our Hylenex product`s market opportunity," said Jonathan Lim, MD, Halozyme`s chairman and CEO. "We are excited to have Baxter as a partner utilizing their world-class sales and marketing capabilities to help develop and commercialize Hylenex in Europe."

"This product will bring significant benefit to patients in many clinical settings," said Daniel Tasse, general manager for Baxter`s Anesthesia, Critical Care and Oncology business. "We look forward to continuing to work with Halozyme to bring Hylenex to market."

Halozyme`s hyaluronidase (rHuPH20) is a recombinant form of the naturally occurring human enzyme and is being investigated for its ability to break down hyaluronic acid (HA), the space-filling gel-like substance that is a major component of tissues throughout the body. Hyaluronidase that is injected in the skin or in the muscle is being studied to determine if it can temporarily digest the HA gel to enhance the penetration and diffusion of other injected drugs or fluids.

[ProMaiLer]

hm, der chart schaut ja bescheiden aus

irgendwie ne komische firma oder?

ok, dass die keine umsätze habe ist ja noch normal. aber außer in 2004 hatten die ja noch nichtmal verluste, also auch keine ausgaben für forschung..

wie kommt denn das?

[BrauchGeld]

@ProMaiLer

Nicht das vergangene zählt sondern was die zukunft bringt, und die aussichten für Halozyme stehen nicht schlecht.
Halozyme hat mit Baxter einen starken partner an der seite und wenn Hylenex nächsten monat zugelassen wird dann kommt auch endlich cash in die kasse.


Halozyme Therapeutics Reports Second Quarter 2005 Financial Results
Monday August 8, 7:45 am ET
- Conference Call and Webcast Today at 8:00 a.m. PDT -


SAN DIEGO, Aug. 8 /PRNewswire-FirstCall/ -- Halozyme Therapeutics, Inc. (Amex: HTI - News), a biopharmaceutical company focused on the development and commercialization of recombinant human enzymes, today reported progress and financial results for the three months ended June 30, 2005.

Second Quarter 2005 and Subsequent Week`s Highlights

* The submission of an Investigational New Drug (IND) application for
Chemophase(TM) to the U.S. Food and Drug Administration (FDA).
Chemophase is a formulation of recombinant human hyaluronidase
being developed as a chemoadjuvant for the treatment of cancer.
This IND was submitted to enable the initiation of the first clinical
trial with Chemophase, administered intravesically (i.e., in the
bladder) with the chemotherapeutic agent mitomycin to patients with
bladder cancer.

* The acceptance by the FDA and the granting of Priority Review status
for Halozyme`s New Drug Application (NDA) for Hylenex(TM). Hylenex,
the first product in Halozyme`s Enhanze(TM) Technology portfolio, is
for potential use as a "spreading agent" to enhance the drug delivery
of local anesthesia, contrast agents and for subcutaneous fluid
replacement, or hypodermoclysis.

* The launch of Cumulase(TM) for the treatment of oocytes to facilitate
certain in vitro fertilization (IVF) procedures. The active
pharmaceutical ingredient in Cumulase is the first and only
recombinant human hyaluronidase approved in the United States and in
the European Union (EU) for cumulus removal in the IVF process.
Halozyme received 510(k) clearance from the FDA in April 2005 and CE
Mark approval in December 2004.

* The presentation of results from new preclinical studies
investigating the use of Halozyme`s rHuPH20 hyaluronidase enzyme in
conjunction with chemotherapy at the American Association for Cancer
Research in Anaheim, California. Studies conducted in collaboration
with the University of Trondheim, Norway, showed rHuPH20 reduced both
tumor interstitial fluid pressure in animal models and the resistance
of cultured human bladder carcinoma aggregates to a commonly used
chemotherapy agent. The company also announced its selection of
bladder cancer as its first therapeutic target for Chemophase in
oncology.

* The presentation of new preclinical study results of Halozyme`s
rHuPH20 hyaluronidase enzyme at the 2005 Association for Research in
Vision and Ophthalmology annual meeting in Fort Lauderdale, Florida.
These preclinical safety and pharmacology animal studies showed that
when viscoelastic agents commonly used in cataract surgery were left
in the eyes of animals, injection of Halozyme`s rHuPH20 enzyme into
the front of the eye significantly reduced the incidence and severity
of intraocular pressure rises.

* The bolstering of Halozyme`s management team with the addition of
Richard C. Yocum, MD, and its Board with the addition of Steve
Thornton. Dr. Yocum joined Halozyme as its new Vice President of
Clinical Development and Medical Affairs and brings to Halozyme more
than 23 years of experience in clinical drug development, project team
management, clinical research trial design and implementation and
patient care. Mr. Thornton brings to the Board more than 27 years of
strategic and operational experience within large and small
pharmaceutical companies in the fields of branded and generic drugs,
medical devices and drug delivery technologies.

Second Quarter 2005 Financial Results

* Net loss for the second quarter of 2005 was $2.9 million, or $0.06
per share, compared with a net loss for the second quarter of 2004 of
$2.1 million, or $0.05 per share. Net loss for the six months ended
June 30, 2005 was $6.1 million, or $0.12 per share compared with a net
loss for the six months ended June 30, 2005 of $3.4 million, or $0.12
per share.

* Research and development expenses for the second quarter of 2005 were
$2.2 million, compared with $1.5 million for the second quarter of
2004, reflecting increased research, development and manufacturing
expenses associated with the Company`s Cumulase and Hylenex product
candidates.

* Selling, general and administrative expenses for the second quarter
of 2005 were $0.8 million, compared with $0.6 million for the second
quarter of 2004, reflecting increased personnel costs and the costs of
being a public company, including accounting and legal expenses.

* Cash and cash equivalents were $10.1 million as of June 30, 2005
compared with $13.1 million at March 31, 2005 and $5.9 million as of
June 30, 2004.

"We continue to make solid progress on all fronts and are meeting our milestones, including launch of our first product Cumulase, as targeted," stated Jonathan Lim, MD, Halozyme`s Chairman and CEO. "We are extremely pleased with our progress toward bringing our oncology drug candidate, Chemophase, into the clinic later this year. Chemophase is designed to enhance the delivery of chemotherapeutic agents to tumor tissue, which may renew response to chemotherapy regimens and potentially increase patient survival. Our goal is to initiate clinical trials in bladder cancer in the fourth quarter of 2005."

[BrauchGeld]

Hallo

Gute Nachrichten für Halozyme !

Halozyme Therapeutics Receives FDA Clearance to Initiate Chemophase Clinical Trial
Thursday August 11, 8:00 am ET


SAN DIEGO, Aug. 11 /PRNewswire-FirstCall/ -- Halozyme Therapeutics, Inc. (Amex: HTI - News), a biopharmaceutical company focused on the development and commercialization of recombinant human enzymes, today announced it has received clearance from the U.S. Food and Drug Administration (FDA) for its Chemophase(TM) Investigational New Drug (IND) application. The initial clinical protocol under this IND is a Phase I study designed to evaluate a single intravesical administration of Chemophase along with mitomycin in patients with superficial bladder cancer.
"We are thrilled to be able to begin our Chemophase study," said Jonathan Lim, MD, Halozyme`s Chairman and CEO. "This novel therapeutic biologic is being developed to enhance the delivery of chemotherapy. Based on the promising pre-clinical data gathered to date, and the previous clinical work done with bovine hyaluronidase in bladder cancer, co-delivery of Chemophase may increase the penetration of mitomycin throughout the tumor and reach residual tumor cells that otherwise might develop into recurrent tumors. We are excited about potentially bringing this therapeutic into the clinic in the fourth quarter, which will represent another important milestone for Halozyme."

According to data from the American Cancer Society, National Cancer Institute, American Urological Association, and Southwest Oncology Group Study, over 180,000 patients present with new or recurrent cases of superficial bladder cancer in the US every year, all of whom would be potential candidates for Chemophase in the event it is approved as first line treatment with mitomycin. The clinical protocol has received Institutional Review Board approval, and the Phase 1 study will enroll up to ten patients to obtain five evaluable patients with superficial bladder cancer. The objectives of the Chemophase clinical trial are to determine the safety, tolerability and pharmacokinetics of Chemophase administered intravesically with mitomycin.

[BrauchGeld]

Hallo

In den letzten 6 wochen haben die institutionellen 1.173.776 aktien gekauft,lediglich 13.200 aktien wurden verkauft.

http://www.nasdaq.com/asp/holdings.asp?mode=&kind=&symbol=ht…

[ProMaiLer]

das stimmt, schaut gut aus

inzwischen sehe ich auch, dass die 2004 6,5 mio dollar in forschung gesteckt haben

das ist doch schonmal was

ein paar insiderkäufe gabs ja auch
http://www.nasdaq.com/asp/holdings.asp?mode=&kind=&timeframe…

[ProMaiLer]

bleibt nur zu hoffen, dass die mit ihren produkten demnächst auch mal was verdienen

10 mio cash bei 2,5 mio verlust im quartal, das reicht nicht mehr all zu lange

[BrauchGeld]

Hallo

@ProMaiLer

Halozyme hat momentan mit Cumulase ein umsatzschwaches produkt auf den markt jahresumsatz etwa 10mio$,aber in 4 wochen könnte das anders aussehen wenn Hylenex zugelassen wird.
Für Hylenex beträgt der markt zwischen 300-400mio$.

[BrauchGeld]

Hallo

Ausbruch scheint unmittelbar bevor zustehen.

http://finance.yahoo.com/q?s=hti

24-Aug-05 RAMSAY, DAVID A
Chief Financial Officer 10,000 Direct Purchase at $1.70 per share. $17,000
23-Aug-05 KENNARD, DON A
Vice President 3,000 Direct Purchase at $1.66 per share. $4,980
23-Aug-05 RAMSAY, DAVID A
Chief Financial Officer 5,000 Direct Purchase at $1.68 - $1.69 per share. $8,4252
23-Aug-05 FROST, GREGORY IAN
Director 5,000 Direct Purchase at $1.69 per share. $8,450

[ProMaiLer]

du hast recht, das schaut wirklcih gut aus

ich geh morgen rein mit ein paar kröten *g*

[ProMaiLer]

was mich etwas stutzig macht ist das

http://www.nasdaq.com/asp/holdings.asp?mode=&kind=&symbol=CE…

da sind 550.000 aktien zum verkauf angemeldet
die verkaufsfrist beträgt 3 monate

die müssen also bis zum 13.10 verkauft sein oder es muss ein neues insider form gestellt werden

[BrauchGeld]

@ProMaiLer

Du bringst einiges durcheinander und zwar wurden in den letzten 3 mon. diese anzahl an aktien verkauft das ist schon alles vorbei.

Ich bin sehr Optimistisch was Halozyme betrifft.

[ProMaiLer]

woher weißt du, dass die verkauft wurden?
form 144 heißt, nicht unternehmensinsider müssen größere verkäufe VORHER melden, also die ABSICHT zu verkaufen

ob die dann auch verkaufen ist deren sache

[BrauchGeld]

Ich denke wir werden diese Woche höhere kurse sehen als die 2$ aktuell.

Halozyme Therapeutics to Present at the Roth Capital Partners New York Conference
Monday August 29, 8:00 am ET


SAN DIEGO, Aug. 29 /PRNewswire-FirstCall/ -- Halozyme Therapeutics, Inc. (Amex: HTI - News), a biopharmaceutical company focused on the development and commercialization of recombinant human enzymes, today announced that the Company will present at the Roth Capital Partners New York Conference to be held September 7-8, 2005 at the Westin New York at Times Square.

Jonathan E. Lim, MD, Halozyme`s Chairman and Chief Executive Officer, is scheduled to speak on Wednesday, September 7, 2005 at 8:00 AM Eastern Time (5:00 AM Pacific Time) in the Gershwin I room and will discuss the Company`s strategic initiatives, product pipeline and market opportunities.

Interested parties can access a live audio web cast of the presentation at www.halozyme.com. A replay of the presentation will be available for 14 days. To register for this conference or for additional information, visit www.rothcp.com.

[BrauchGeld]

Hat leider nicht hingehauen mit den höheren kursen,anscheinend wollen einige weiterhin kurse um die 2$ sehen.

Ich denke die Zulassung am Freitag wird Halozyme genug auftrieb geben hoffe ich zumindest.

[ProMaiLer]

bin gespannt

[ProMaiLer]

NEW YORK--(BUSINESS WIRE)--Sept. 13, 2005--

Rodman & Renshaw, LLC Initiates Coverage of Halozyme Therapeutics,
Inc. With A Market Outperform Rating;
Analyst Sets 12 Month Target Price of $2.88

Rodman & Renshaw, LLC initiated research coverage of Halozyme Therapeutics, Inc. (Amex: HTI) with a Market Outperform Rating and a 12-month price target $2.88. Matthew N. Murray, Senior Biotechnology Analyst, issued the report.

[ProMaiLer]

schaut garnicht schlecht aus

[ProMaiLer]

gibt einige neue reports auf yahoo

17-Sep-2005 Reuters Estimates N/A Reuters Estimates company report - Halozyme Therapeutics, Inc. (USD)

20-Sep-2005 Reuters Investment Profile N/A Halozyme Therapeutics, Inc.: Business description, financial summary, 3yr and interim financials, key statistics/ratios and historical ratio analysis.

21-Sep-2005 ValuEngine, Inc. N/A ValuEngine Quantitative Summary Report for HTI: Quantitative data, forecast report. Based on Academic Valuation models.

22-Sep-2005 ValuEngine, Inc. N/A ValuEngine Quantitative Research Report for HTI: Forecasts, market valuations, comparables, quantitative summary and financials. Based on proprietary Academic Valuation models.

[BrauchGeld]

Hallo

Halozyme steigt aktuell um 10% bin gespannt wann heute die Zulassung kommt.

http://finance.yahoo.com/q?s=hti

[ProMaiLer]

ich auch

[BrauchGeld]

Hallo

Wird noch etwas dauern mit der Zulassung !

Halozyme Hylenex Decision Delayed by FDA
Monday September 26, 11:04 am ET
Halozyme Says FDA Hylenex Decision Is Delayed As Agency Continues Review of Application


SAN DIEGO (AP) -- Biopharmaceutical company Halozyme Therapeutics Inc. said Monday that the Food and Drug Administration is still reviewing its application for Hylenex and does not know when the agency will make a decision on the drug dispersion agent.
Halozyme shares fell 24 cents, or 11 percent, to $1.96 in morning trading on the American Stock Exchange. The stock has fluctuated between $1.50 and $3.10 in the past 52 weeks, and is down about 11 percent so far this year.

On March 23, the company submitted its application to the FDA for Hylenex and soon after received a "priority review" for the product. Priority reviews take about six months to complete from the time the application is filed rather than the standard 10 months.

Hylenex is an injected product that uses a human enzyme to improve the dispersion and absorption of other injected drugs, an alternative to animal-derived products currently in use.

[BrauchGeld]

Hallo

Halozyme Therapeutics Presents Novel Stroke Data at the 2005 American Neurological Association Annual Meeting
Tuesday September 27, 8:00 am ET
- Modified Recombinant Human Hyaluronidase Demonstrates Increased Survival in Preclinical Stroke Models -


SAN DIEGO, Sept. 27 /PRNewswire-FirstCall/ -- Halozyme Therapeutics, Inc. (Amex: HTI - News), a biopharmaceutical company focused on the development and commercialization of recombinant human enzymes, presented new pharmacokinetic and efficacy data with a novel, chemically modified form of a recombinant human hyaluronidase enzyme in animal ischemic stroke models. The data were presented at the 2005 American Neurological Association annual meeting in San Diego.
ADVERTISEMENT


The enzyme, called rHuPH20, when conjugated to polyethylene glycol (PEG), demonstrated a dramatically longer serum half life (approximately 100 fold) compared with the unmodified form, thereby preventing it from being rapidly cleared from circulation. Both rHuPH20 and PEG-rHuPH20 demonstrated increased survival in stroke models.

When injected intravenously in rodent models of severe ischemic stroke, enzyme treated animals showed significantly increased survival compared to saline controls over 28 days after stroke. Survival at 28 days post- infarction improved to 69% in the group receiving 50µg/kg rHuPH20, from 48% in saline controls, two hours post-infarction and every 48 hours thereafter for 14 days (p=0.049, n=40 animals per group). When rHuPH20 was conjugated with polyethylene glycol, survival in the same rat MCAO model increased to 78% (p=0.006, n=40 animals per group). The enzyme appeared to prevent death in treated animals by reducing edema (or swelling) within the brain. Brain edema can occur after severe strokes when large regions of the brain are deprived of blood flow. These findings are of particular interest in that reducing edema in ischemic stroke patients may limit the deadly progression of the disease that can occur due to uncontrollable pressure rises. Such increased edema and pressure rises also occur with other conditions, including cardiovascular disease, tumors, and organ transplantation.

"This is extremely encouraging work, and suggests potential utility in reducing brain injury from edema in ischemic stroke," commented Gregory Del Zoppo, MD, Associate Professor of The Scripps Research Institute and world- renowned expert in novel stroke therapeutics. "Future studies are warranted that could potentially lead to exciting data and translate into real clinical benefit."

"While hyaluronidase enzymes have been tested in the clinic previously by intravenous administration, few studies have examined the pharmacokinetics of these molecules," said Gregory Frost, PhD, Halozyme`s Vice President and Chief Scientific Officer. "A significant limitation for intravenous use has been their remarkably short half life. Modifying the human enzyme with PEG to produce a greatly improved half life while keeping the enzyme catalytically active represents a significant achievement for the scientific team at Halozyme and potentially opens new avenues for future development."

Halozyme`s family of recombinant human glycosaminoglycan degrading enzymes are being studied for their ability to degrade hyaluronic acid (HA) and other glycosaminoglycans in the body for drug delivery and for treatment of medical conditions resulting from pathologic accumulation of these materials.

[BrauchGeld]

Hallo

Halozyme steigt um 6% auf 2,25$ erreicht damit ein neues 6 monatshoch.

A Rush of Blood to the Head
at SmartMoney.com

HALOZYME THERAPEUTICS (HTI) is proving to be a testament to efficiency. The tiny San Diego biotech, with a market capitalization of just $102 million, has found yet another potential use for the recombinant human enzyme that it has developed.
Halozyme presented preclinical data this week at the annual meeting of the American Neurological Association in San Diego that showed its injectable enzyme, known as rHuPH20, could be used to help treat stroke victims. It seems the enzyme works as a kind of lubricant, dissolving obstructions and helping blood make its way to and throughout the brain. Based on testing in rats that suffered strokes, the company said rHuPH20, when used in conjunction with a blood thinner, improved the rodents` chances of survival by 30%.

"The preclinical data that was recently presented at ANA by Halozyme indicate that its product could help stroke patients and generate significant sales in five to seven years," says Matthew Murray, senior biotechnology analyst at Rodman & Renshaw, an investment bank in New York. (Murray doesn`t own shares of Halozyme; Rodman & Renshaw has an investment-banking relationship with the company.)

Halozyme already has one drug based on a formulation of the enzyme on the market, a second nearing Food and Drug Administration approval and a third drug entering early stage human testing.

Cumulase, which hit the shelves in June, helps foster in-vitro fertilization by clearing away the fibrous materials surrounding extracted eggs, thus making artificial fertilization easier. The company put the global market for the drug in 2004 at roughly 500,000 procedures. Jonathan Aschoff, of Brean Murray & Co., an investment bank in New York, says the total dollar market for the drug is between $10 million and $20 million. (Aschoff doesn`t own shares of Halozyme; Brean Murray & Co. has an investment-banking relationship with the company.)

For the second quarter, the first period in which Cumulase was on the market, Halozyme posted total revenue of just $45,703 — all from sales of the in-vitro drug. The quarterly net loss added up to $2.9 million, or six cents a share, vs. $2.1 million, or five cents a share, a year earlier. The company had 10.5 million fewer shares outstanding in the second quarter of 2004. Halozyme had $10.1 million in cash as of June 30, down from $13.1 million on March 31.

Investors` reactions to news of the stroke indication have been muted. The thinly traded stock jumped 10% to $2.20 last Friday in the run-up to the conference, on the heaviest volume it has seen in six months. But most of those gains were returned this week, with the stock sliding back to $2.05, well below the 52-week high of $3.10 but better than the year low of $1.50. Why the give-back? On Monday came news of a regulatory delay of another formulation of the rHuPH20 enzyme.

Hylenex, which acts as a spreading agent to speed the dispersion of other injectable drugs such as local anesthesia or contrast agents, had been scheduled to be approved by the FDA this month. Halozyme announced Monday that the agency had delayed its decision indefinitely, pending further review of submitted data. The silver lining? Analysts say the delay might have more to do with the turmoil caused by the leadership turnover at the agency than the drug itself.

The market for Hylenex is potentially much larger than that of Cumulase because it has diverse applications. In ophthalmology, for example, doctors could use it to increase the spread of numbing drugs administered to the eye before cataract surgery. Annual revenue from Hylenex could reach $12 million in 2007 and could peak at $110 million in 2017, says Rodman & Renshaw`s Murray.

Meanwhile, there`s Chemophase, a much stronger version of Hylenex, which was approved by the FDA on Aug. 11 for Phase I clinical trials in the treatment of solid tumors associated with bladder cancer. Murray estimates Chemophase revenues could reach $5.1 million in 2009 and could climb to $50 million by 2020. Conventional chemotherapy is occasionally ineffective on bladder cancer because tumors can become blocked by walls of obstructive cells. Chemophase is designed to obliterate those cells, thereby clearing a path for the chemotherapy drugs to reach the tumors.

Long-term investors will keep a close eye on Halozyme`s stroke formulation, which hasn`t been branded yet but could prove to be the most lucrative indication in the end. About 700,000 Americans will have strokes in 2005, according to the American Heart Association, and stroke is the third most prevalent cause of death in the U.S.

[BrauchGeld]

Verdammtes FDA pack lässt sich ganz schön zeit mit der Zulassung.
In der Konferenz gestern hiess es die Zulassung erwarte man noch vor 2006.

Halozyme Therapeutics Reports Third Quarter 2005 Financial Results
Friday November 11, 8:00 am ET
- Conference Call and Webcast Today at 8:00 a.m. PDT -


SAN DIEGO, Nov. 11 /PRNewswire-FirstCall/ -- Halozyme Therapeutics, Inc. (Amex: HTI - News), a biopharmaceutical company focused on the development and commercialization of recombinant human enzymes, today reported progress and financial results for the three months ended September 30, 2005.
"We continue to make solid progress on all fronts and are meeting our milestones, including the initiation of our Chemophase(TM) Phase I clinical trial, as targeted," stated Jonathan Lim, MD, Halozyme`s Chairman and CEO. "We are extremely pleased with the advancement of our oncology drug candidate, Chemophase, into the clinic. Chemophase is designed to enhance the delivery of chemotherapeutic agents to tumor tissue, which may renew response to chemotherapy regimens and potentially increase patient survival."


Third Quarter 2005 and Subsequent Week`s Highlights

* The initiation of patient enrollment for the Chemophase Phase I
clinical trial and the dosing of two patients. Chemophase is a novel
recombinant therapeutic being developed to enhance the delivery of
chemotherapy. The initial clinical protocol for Chemophase is designed
to evaluate a single intravesical (into the bladder) administration of
Chemophase with the widely used anticancer drug mitomycin in patients
with superficial bladder cancer. The Phase I study will enroll at
least five evaluable patients with superficial bladder cancer. The
objectives of the study are to determine the safety, tolerability and
pharmacokinetics of Chemophase administered intravesically with
mitomycin. The study is being conducted at BCG Oncology in Phoenix,
Arizona under the supervision of Donald L. Lamm, MD, the principal
investigator.

* The presentation of new pharmacokinetic and efficacy data with a novel,
chemically modified form of a recombinant human hyaluronidase enzyme in
animal ischemic stroke models. The data were presented at the 2005
American Neurological Association annual meeting in San Diego. The
enzyme, called rHuPH20, when conjugated to polyethylene glycol (PEG),
demonstrated a dramatically longer serum half life (approximately 100-
fold) compared with the unmodified form, thereby preventing it from
being rapidly cleared from circulation. Both rHuPH20 and PEG-rHuPH20
demonstrated increased survival in stroke models.

* The indication by Baxter of its desire to market, sell, and distribute
Hylenex(TM) in the European Union, on an exclusive basis. Hylenex is a
local formulation of recombinant human hyaluronidase under development
for use as a "spreading agent" to enhance the delivery of local
anesthesia, contrast agents, and for subcutaneous fluid replacement
(also called hypodermoclysis). The parties are currently negotiating
the definitive agreement. If the parties are unable to reach mutual
agreement on terms, Baxter`s option will expire. Halozyme filed a New
Drug Application in the United States for Hylenex on March 23, 2005 and
is awaiting a response to the application by the FDA.

Third Quarter 2005 Financial Results

* Net loss for the third quarter of 2005 was $3.7 million, or $0.07 per
share, compared with a net loss for the third quarter of 2004 of $3.3
million, or $0.08 per share. Net loss for the nine months ended
September 30, 2005 was $9.8 million, or $0.20 per share compared with a
net loss for the nine months ended September 30, 2004 of $6.6 million,
or $0.21 per share.

* Research and development expenses for the third quarter of 2005 were
$3.2 million, compared with $2.6 million for the third quarter of 2004,
reflecting increased research, development and manufacturing expenses
associated with the Company`s Cumulase, Hylenex and Chemophase product
candidates.

* Selling, general and administrative expenses for the third quarter of
2005 were $0.6 million, compared with $0.7 million for the third
quarter of 2004, reflecting a decrease in legal expenses during the
current quarter.

* Cash and cash equivalents were $6.6 million as of September 30, 2005,
compared with $10.1 million at June 30, 2005, and $3.5 million as of
September 30, 2004.

[BrauchGeld]

Hallo

Endlich Halozyme hat die Zulassung erhalten.
Jetzt heisst es zurücklehnen und zusehen wie das Unternehmen wächst.

Halozyme Therapeutics and Baxter Healthcare Corporation Announce FDA Approval of Hylenex
Monday December 5, 8:00 am ET
Approval Marks the First Recombinant Human Hyaluronidase Approved for Use as an Adjuvant Drug to Increase the Absorption and Dispersion of Other Injected Drugs


SAN DIEGO, and DEERFIELD, Ill., Dec. 5 /PRNewswire-FirstCall/ -- Halozyme Therapeutics, Inc. (Amex: HTI - News), a biopharmaceutical company focused on the development and commercialization of recombinant human enzymes, and Baxter Healthcare Corporation announced today that the U.S. Food and Drug Administration (FDA) has approved Halozyme`s Hylenex recombinant (hyaluronidase human injection) for use as an adjuvant agent to increase the absorption and dispersion of other injected drugs. Baxter will market and sell Hylenex, a proprietary recombinant human hyaluronidase, in the United States.

"We are thrilled that the FDA has approved our first NDA filing," said Jonathan Lim, MD, Halozyme`s Chairman and CEO. "This is a landmark achievement for Halozyme. We believe Hylenex will help enhance the practice of medicine by offering healthcare providers and their patients a human recombinant product as an adjuvant to increase the absorption of other injected drugs."

"We look forward to using our expertise and strong channels to successfully launch Hylenex, allowing patients in many clinical settings to benefit from the product manufactured with this promising technology," said Daniel Tasse, general manager of Baxter`s Anesthesia, Critical Care and Oncology business. "We will continue to work with Halozyme to help clinicians fully realize the drug delivery and administration benefits this product offers."

Results from a clinical trial conducted to support the Hylenex NDA demonstrated no allergic reactions to Hylenex and significantly reduced injection site discomfort. The double-blinded clinical study compared Hylenex to a saline control in 100 human volunteers. These volunteers were injected intradermally with Hylenex in one forearm and saline control in the other forearm, and evaluated for allergic responses and injection site side effects. The data showed injection site discomfort (e.g., stinging, burning, other discomfort) of 28% in the saline arm and 3% in the Hylenex arm.

[BrauchGeld]

Die Amis scheinen endlich aufgewacht zu sein.

Volumen up and Share price up:

http://finance.yahoo.com/q?s=hti

[BrauchGeld]

Halozyme dürfte in den folgenden tagen neue hochs sehen ,ein gutes langfrist investment.

On December 8, 2005, Halozyme Therapeutics, Inc. ("Halozyme") and Baxter Healthcare Corporation ("Baxter") entered into a Second Amendment (the "Second Amendment") to the Exclusive Distribution Agreement between Halozyme and Baxter that was originally entered into on August 13, 2004.
Under the terms of the Second Amendment, Baxter will market and sell Halozyme`s Hylenex product on an exclusive basis in the member countries of the European Union (the "EU"), as well as selected other European countries (such additional countries, along with the member countries of the EU, are referred to as the "Additional Territory"), pending the applicable regulatory approvals of Hylenex in the Additional Territory. Baxter and Halozyme will equally share in the costs associated with obtaining such approvals. The Second Amendment provides that Baxter will also pay annualized sales and marketing costs up to an agreed upon amount. If Baxter`s sales and marketing costs exceed the agreed upon amount, additional annual costs will be split equally between Halozyme and Baxter provided that the parties first mutually agree on the amount of such additional costs. In addition, Halozyme will receive fifty percent of the gross profit from the sales of Hylenex in the Additional Territory.

[BrauchGeld]

Auch hier stehen die Ampeln auf grün !

[BrauchGeld]

Hallo

Halozyme ist ein gutes Investment ,es braucht nur mehr aufmerksamkeit dann werden wir neue hochs sehen.
Momentan sieht es auch chartmässig wieder gut aus.

Halozyme Therapeutics and Baxter Release Results From the INFUSE-LR Study
Wednesday February 8, 4:05 pm ET
- Use of Hylenex Accelerates Subcutaneous Flow Rates With Acceptable Tolerability -


SAN DIEGO, and DEERFIELD, Ill., Feb. 8 /PRNewswire-FirstCall/ -- Halozyme Therapeutics, Inc. (Amex: HTI - News) and Baxter Healthcare Corporation today announced the results of INFUSE-LR, a clinical trial of subcutaneous (Sub-Q) infusion (hypodermoclysis) with Hylenex. The use of Hylenex preceding Sub-Q infusion accelerated the flow rate by approximately four-fold versus the Sub-Q infusion with placebo, while causing less edema and was preferred by both investigator (for 92% of subjects) and study subjects (92%).

Hylenex is a liquid injectable formulation that includes the active pharmaceutical ingredient, recombinant human hyaluronidase (rHuPH20), which is approved by the U.S. Food and Drug Administration (FDA) for use as a spreading agent to increase the absorption and dispersion of other injected drugs and for Sub-Q hydration. Subcutaneous hydration is the introduction of fluids under the skin to replace inadequate intake or excessive loss of water and electrolytes during illness or operation.

The INcreased Flow Utilizing Subcutaneously-Enabled Lactated Ringer`s clinical trial, or INFUSE-LR study, was designed to determine the subcutaneous infusion flow rate of Lactated Ringer`s (LR) solution with and without Hylenex, determine the Sub-Q infusion flow rate dose response to Hylenex over one order of magnitude of dose, and assess safety and tolerability. This prospective, double-blind, randomized, placebo-controlled, within-subject, dose-comparison study enrolled 54 volunteer subjects who received Sub-Q infusions simultaneously in both upper arms through 24 gauge catheters. Key results from the study include:


The use of Hylenex compared to placebo preceding Sub-Q infusion, under
gravity flow, to accelerate the flow rate was assessed. Hylenex
accelerated flow versus placebo in every subject studied, and by an
overall mean ratio of approximately four-fold. The overall mean flow rate
for Sub-Q infusion with Hylenex was 464 mL/hr versus 118 mL/hr with
placebo (p<0.0001).

The faster flow rates did not result in an increase in edema. A total of
94% of subjects had moderate or severe arm edema with placebo compared to
17% with Hylenex (p<0.0001).

The Sub-Q infusion rate, when preceded by Hylenex, was closer in flow to
the IV infusion (ratio of 2.6) than to the Sub-Q infusion rate with
placebo (ratio of 2.9), based on ratios of flow rates in five subjects in
the pilot phase of the study.

At end-infusion, an average pain score of 5.8 was reported by study
subjects for Hylenex infusions versus 9.6 for placebo (p=0.002). The
overall degree of pain/discomfort in both study arms was low and may not
be clinically meaningful.

In the study, there were no serious or severe adverse events (AE). Based
on the AE profile, Hylenex was at least as well tolerated as placebo.

In a global preference ranking, both subjects and the Investigator
preferred, in 92% of cases, using Hylenex with Sub-Q infusions rather than
placebo (p<0.0001).

While the 750 and 1,500 unit doses produced faster flow rates than the 150
unit dose, the study was not statistically powered to detect a dose
response. All doses of Hylenex demonstrated faster flow rates than
placebo and acceptable tolerability.

Hylenex is the first and only FDA-approved hyaluronidase from a recombinant human source. Although animal-derived hyaluronidase extracts have been demonstrated in the literature to accelerate Sub-Q infusions, this is the first clinical trial of the recently FDA-approved recombinant human hyaluronidase for use in Sub-Q infusion and is believed to be the first clinical trial of any hyaluronidase product to show reduced discomfort associated with Sub-Q infusion. This study demonstrates that it is feasible to use Hylenex with Sub-Q infusions of LR using gravity flow without an infusion pump to achieve substantial flow rates with acceptable tolerability.

[BrauchGeld]

Halozyme Therapeutics Announces Notice of Allowance for Patent Claims to Second Human Enzyme
Monday February 13, 8:00 am ET


SAN DIEGO, Feb. 13 /PRNewswire-FirstCall/ -- Halozyme Therapeutics, Inc. (Amex: HTI - News), a biopharmaceutical company developing and commercializing recombinant human enzymes, announced today that the US Patent Trademark Office has given a notice of allowance to both natural and recombinant forms of HTI-101, a second enzyme in Halozyme`s pipeline. The patent is licensed exclusively to Halozyme from the University of California, San Francisco. The new patent claims for HTI-101 are directed to a human enzyme normally found in the bloodstream with a mechanism of action that is distinct from Halozyme`s FDA approved rHuPH20 enzyme. This new enzyme may prove useful for additional therapeutic applications. Halozyme is currently conducting pre-clinical work with HTI-101 in the fields of oncology and inflammation.

"We are pleased to add these new natural and recombinant composition of matter claims in the `283 patent to Halozyme`s growing human enzyme intellectual property estate," said Gregory Frost, PhD, Halozyme`s Chief Scientific Officer. "This second enzyme can be readily channeled into our commercially validated molecular engineering systems and mammalian manufacturing processes, and fits nicely with Halozyme`s demonstrated ability to develop and commercialize recombinant human enzymes."

[BrauchGeld]

Hallo

Die Institutionellen sind kräftig am kaufen ,Deutsche Bank und Baker Bros. u.a. sind neu dabei.

http://www.nasdaq.com/asp/holdings.asp?mode=&kind=&timeframe…

[BrauchGeld]

Seit einigen tagen wird diese aktie massivst gekauft.
Naja es wurde auch zeit das Halozyme steigt .