Cypress Bioscience in license deal. Bristol-Meyers returns cancer drug to Exelixis. Biovail gains. Affymax plunges. Positron announces sales of PET scanners Print E-mail
By BioMedReports.com Staff   
Monday, 21 June 2010 18:24
Below is a list of the companies that made news in the healthcare sector on Monday, June 21, 2010.

Cypress Bioscience, Inc. (NASDAQ: CYBP) fell more than 37% today after the company announced that it has entered into an exclusive North American license for the development and commercialization of BioLineRx's novel antipsychotic (BL-1020, hereafter, CYP-1020), a potential breakthrough treatment for schizophrenia.

Out of the gate Cypress will pay BioLineRx $30 million and will include potential clinical and regulatory milestones of up to $160 million, potential commercial miletones of $85 million and an additional $90 million potentially for approval of additional indications in the U.S. as well as for approval in other countries in North America. Cypress also said that it will assume funding funding for all develope and will pay royalties on sales to BioLineRx.

"This agreement reflects our renewed strategic focus on R&D, where we have successfully demonstrated leadership, creativity and a competitive advantage," said Jay D Kranzler, MD, PhD, Chairman and Chief Executive Officer of Cypress Bioscience. "This transaction represents a step down a path that we have successfully navigated before -- late stage, innovative drug development of a novel compound to address a significant unmet medical need.

Shares of Cypress were sent lower on the news as investors viewed the deal as being negative in the near term for the company. Shares closed down $1.64 to $2.70.

Exelixis, Inc. (Nasdaq:EXEL) today announced that it has regained full rights to develop and commercialize XL184. Exelixis and Bristol-Myers Squibb Company (BMS) entered into a global development collaboration for XL184, the clinically most advanced MET inhibitor, in December 2008. Under the agreement, BMS and Exelixis had originally agreed to certain clinical development plans, and Exelixis maintained key rights regarding timing and funding of current and future clinical trials. Given the recent progress of BMS’ wholly-owned oncology pipeline and positive data generated by XL184, Exelixis and BMS were not able to align on the scope, breadth and pace of the ongoing clinical development of XL184. As a result, BMS returned XL184 to Exelixis, thereby giving Exelixis the opportunity to advance the program as originally envisioned. BMS will make a payment to Exelixis of $17 million in connection with the return of XL184.

"We believe in the clinical and commercial potential of XL184 in a broad array of cancer indications. The data that we recently presented at ASCO were encouraging," said George A. Scangos, Ph.D., president and chief executive officer of Exelixis. "We certainly understand BMS’ need to make pipeline and prioritization decisions, but from Exelixis’ perspective, XL184 is our most advanced compound, the data are encouraging, and we need to rapidly develop the compound in indications justified by the data, including medullary thyroid cancer, glioblastoma, and potentially some of the major tumor types being evaluated in the randomized discontinuation trial. We regret BMS’ decision, but we are pleased to now have the opportunity to develop XL184 independent of divergent pipeline and portfolio considerations. It is a sign of the strength of our relationship that we could achieve this outcome for XL184 at the same time that we continue our positive collaborations around a number of other compounds. We have the resources to take XL184 forward on our own for some time and we see several attractive longer term options, which we are currently evaluating."

Shares of Exelixis fell more than 16% ending the day at $3.84, down 74 cents.

Biovail (NYSE:BVF) announced today that the Canadian based company would be buying Aliso Viejo CA. based Valeant Pharmaceuticals International (NYSE: VRX) in a deal worth about 3.3 billion dollars. The combined company will be known as the new Valeant and will specialize in treatments and products for central nervous system disorders and dermatology and will result in an estimated $175 million annual cost savings.

Valeant shareholders will receive a one-time cash dividend of $16.77 a share and 1.7809 shares of Biovail stock that they currently own. Upon completion of the deal, Biovail shareholders will realize a 50.5% ownership in the new entity.

Shares of Biovail soared more than 14% on the news, rising $2.07 to $16.67. Shares of Valiant rose $1.03 or 2.25% to $46.90.

Affymax, Inc. (Nasdaq: AFFY) saw its shares plunge more than 68% Monday after the company reported, along with its partner Takeda, data from its late stage study for Hematide that raised safety concerns. The experimental drug being developed for anemia showed a higher rate of cardiovascular events which included death and stroke in those patients suffering from renal failure but not on dialysis.

The drug did however meet its primary endpoints of the studies, working as well as Amgens Epogen and Aranesp in maintaining a patients hemoglobin. Affymax CEO Arlene M. Morris commented: "We are continuing to evaluate the data, in particular the non-dialysis studies, and the impact on the timing of an NDA submission,"

Analyst expressed concerns with regards to regulatory approval because of the safety issues although some pointed out that it may be possible for Affymax to apply for approval in patients on dialysis, a smaller segment.

Shares of Affymax were rocked on the news, falling $15.83 to close Monday's session at $7.18.

Positron Corporation (OTCBB: POSC) announced the sales of four Attrius™ PET scanners to prominent cardiology practices and orders six Attrius™ PET scanners from its joint venture, Neusoft Positron Medical Systems for immediate delivery.

As a result of the Centers for Medicare & Medicaid Services (CMS) 2010 Medicare Physician Fee Schedule whereby reimbursement for cardiac PET increased and reimbursement for SPECT decreased there has been a significant increase in demand for cardiac PET imaging. When combining the economic and medical imaging advantages of cardiac PET compounded with the continued shortage of Molybdenum, the parent radioisotope used in SPECT imaging, this increase in the demand for cardiac PET is a trend that is expected to continue.

Aeterna Zentaris Inc. (TSX: AEZ; Nasdaq: AEZS), announced that a poster on its oral synthetic growth hormone secretagogue/ghrelin receptor agonist, AEZS-130, was presented yesterday at the 92nd Annual Endocrine Society (ENDO) Meeting and Expo, which is held through June 22, 2010 at the San Diego Convention Center in San Diego, California. The preclinical data showed that AEZS-130 is a potent and safe oral synthetic Growth Hormone (GH) releasing compound with potential utility as a diagnostic test for growth hormone deficiencies, as well as a therapeutic for a range of diseases including treatment of cancer induced cachexia. AEZS-130 is currently in a Phase 3 trial as a diagnostic test for GH deficiency in adults.

BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) commented today that the recommendation on June 18, 2010 by the FDA Advisory Committee regarding the safety and efficacy of flibanserin (Boehringer-Ingelheim) will have no impact on its own ongoing development program or approval pathway for LibiGel (testosterone gel), for the treatment of hypoactive sexual desire disorder (HSDD). The FDA Advisory Committee voted that flibanserin for treatment of HSDD did not show that its benefits outweighed its side effects, among which are daytime sleepiness, dizziness, nausea, and fatigue. Importantly, the Committee concluded that HSDD is a significant medical issue for women.

In a seperate announcement the company reported that the independent Data Monitoring Committee (DMC) of the ongoing LibiGel® Cardiovascular (CV) and Breast Cancer Safety Study unanimously recommended study continuation without modifications, after its third review of the study’s unblinded safety data. The review was based on data from almost 1,500 women-years of exposure. LibiGel is in development for the treatment of female sexual dysfunction (FSD), specifically, hypoactive sexual desire disorder (HSDD) in menopausal women, for which there is currently no FDA approved product. BioSante anticipates the submission of a new drug application (NDA) for LibiGel in 2011.

Cadence Pharmaceuticals, Inc. (Nasdaq:CADX), a biopharmaceutical company focused on in-licensing, developing and commercializing proprietary product candidates principally for use in the hospital setting, announced today that it has signed an agreement providing Cadence with an exclusive option to acquire Incline Therapeutics, Inc., a privately held specialty pharmaceutical company.

Javelin Pharmaceuticals, Inc. (NYSE -- Amex: JAV) announced that on June 18, 2010, Business Wire, a news release service, inadvertently issued a hoax press release titled "US Supreme Court split – rules in favor of Big Pharma" that falsely identified Javelin Pharmaceuticals, Inc. as the issuer of the information. The information in the release was false. Business Wire received the hoax release from an unknown third party, purporting to be an authorized representative of the company, and issued the release for pick-up by national news outlets at 11:19 p.m. EDT on Friday, June 18th.

Javelin personnel quickly saw the hoax release and notified Business Wire immediately. Business Wire issued a retraction at approximately 7:45 a.m. EDT on Saturday, June 19, 2010.

Javelin has confirmed that Javelin’s electronic mail system was not used for the hoax and was not compromised. Law enforcement authorities have been contacted. Similar incidents involving at least two other companies and a different news release service occurred last week.

OncoGenex Pharmaceuticals, Inc. (NASDAQ:OGXI) announced today the initiation of a Phase 3 registration trial of custirsen sodium (OGX-011/TV-1011), its lead product candidate being developed for the treatment of castrate-resistant prostate cancer (CRPC). This trial, referred to as the Prostate Cancer SATURN Trial, is the first of three Phase 3 trials to be initiated under a global collaboration and license agreement between OncoGenex and Teva Pharmaceutical Industries (NASDAQ:TEVA) to develop and commercialize OGX-011/ TV-1011.

Also Monday:

AMRI (NASDAQ: AMRI) announced today that AMRI Senior Vice President, Administration and Chief Financial Officer Mark T. Frost will present at the Wells Fargo Securities Healthcare Conference on Wednesday, June 23, 2010 at 8 a.m. EDT.

Aradigm Corporation (OTCBB:ARDM) today announced that it has entered into a definitive agreement for the sale of common stock and warrants to three existing shareholders and one new investor in a private placement for aggregate gross proceeds of approximately $5 million.

AVEO Pharmaceuticals, Inc. (NASDAQ: AVEO), a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics, today announced that Tuan Ha-Ngoc, president and chief executive officer of AVEO, will close the NASDAQ stock market on Tuesday, June 22, 2010.

BioTech Medics, Inc. (PINKSHEETS:BMCS) On June 9, 2010 BioTech announced in compliance of SEC "material event" regulations that a Federal Grand Jury had criminally indicted 10 persons (none of whom are current board members) regarding alleged illegal stock manipulation, theft, forgery of shares and crimes.

Covidien plc (NYSE: COV) today announced that its wholly-owned subsidiary, Covidien International Finance S.A. (CIFSA), priced an offering of $500 million aggregate principal amount of 1.875% senior notes due 2013, $400 million aggregate principal amount of 2.80% senior notes due 2015 and $600 million aggregate principal amount of 4.20% senior notes due 2020.

Cypress Bioscience, Inc. (NASDAQ: CYPB) announced that Cypress has entered into an exclusive North American license for the development and commercialization of BioLineRx's novel antipsychotic (BL-1020, hereafter, CYP-1020), a potential breakthrough treatment for schizophrenia.

Dyadic International, Inc. (Pink Sheets: DYAI), a global biotechnology company whose cutting-edge C1 platform technology addresses the needs of the multi-billion dollar biofuels market by producing enzymes at industrial scale which efficiently convert biomass into ethanol and other forms of alternative energy, announced today that it has engaged the influential consulting firm, The Abraham Group, to provide strategic advice and transactional assistance to Dyadic, as its exclusive biofuels client, as it actively pursues licensing opportunities and other strategic collaborations throughout the world.

Dyax Corp. (NASDAQ: DYAX) and Defiante Farmaceutica S.A., a subsidiary of the pharmaceutical company Sigma-Tau SpA (Sigma-Tau), announced today a strategic partnership to develop and commercialize subcutaneous DX-88 (ecallantide) for the treatment of hereditary angioedema (HAE) and other therapeutic indications throughout Europe, North Africa, Middle East and Russia.

Forest Laboratories, Inc. (NYSE: FRX) and Merz Pharmaceuticals GmbH announced today that NAMENDA XR(TM) (memantine hydrochloride) was approved by the U.S. Food and Drug Administration for the treatment of moderate to severe dementia of the Alzheimer's type.

GTx, Inc. (Nasdaq: GTXI) announced that Ostarine™ (GTx-024, formerly MK-2866) increased lean body mass and leg press strength in a head to head study evaluating Ostarine and another selective androgen receptor modulator (SARM), MK-3984, in postmenopausal women.

Idera Pharmaceuticals, Inc. (Nasdaq: IDRA) today announced the election of Eve E. Slater, M.D., F.A.C.C., to the Company's Board of Directors as a class III director.

Inovio Pharmaceuticals, Inc. (NYSE Amex:INO), a leader in the development of therapeutic and preventive vaccines against cancers and infectious diseases, announced today that the company is set to be added to the broad-market Russell 3000® Index when Russell Investments reconstitutes its comprehensive set of U.S. and global equity indexes on June 25, according to a preliminary list of additions updated on June 18.

Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announced today that it will webcast its Investor and Analyst Day at the Eventi hotel in New York City on June 24, 2010 from 4:15 p.m. to 5:45 p.m. Eastern time (1:15 p.m. to 2:45 p.m. Pacific).

Mead Johnson Nutrition Company (NYSE: MJN) announced today that it had extended its supply agreement with Martek Biosciences Corporation for DHA (docosahexaenoic acid) and ARA (arachidonic acid) for use in its infant formula products.

Medtronic, Inc. (NYSE:MDT) today announced the launch of KYPHON ActivOs 10 Bone Cement with Hydroxyapatite, a polymethylmethacrylate (PMMA) bone cement containing hydroxyapatite (HA) for use in the treatment of patients with vertebral compression fractures (VCFs) who are undergoing minimally invasive surgery with KYPHON® Balloon Kyphoplasty.

NanoViricides, Inc. (OTC BB: NNVC.OB) reports that its anti-Dengue drug candidates demonstrated significant protection in the initial animal survival studies of Dengue virus infection.

Simulations Plus, Inc. (NASDAQ: SLP), a leading provider of software for pharmaceutical discovery and development, today released preliminary revenues for its third fiscal quarter ended May 31, 2010.

Biotech investors interested in seeing more details about these companies and a full list of their related stories can do so by typing the stock ticker symbol into the Stock Quotes box on the right side of the page.




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