|Idenix falls on FDA clinical hold. After the bell: ZymoGenetics acquired, shares soar|
|By Mary Davila|
|Tuesday, 07 September 2010 18:33|
After the bell Tuesday, Bristol-Myers Squibb Company (NYSE:BMY) and ZymoGenetics, Inc. (NASDAQ: ZGEN) announced today that the companies have signed a definitive agreement providing for the acquisition of ZymoGenetics by Bristol-Myers Squibb, for $9.75 per share in cash. The transaction, with an aggregate purchase price of approximately $885 million, or approximately $735 million net of cash acquired, has been unanimously approved by the boards of directors of both companies. The board of directors of ZymoGenetics intends to recommend that ZymoGenetics’ shareholders tender their shares in the tender offer. In addition, shareholders holding approximately 37% of the outstanding shares of ZymoGenetics’ common stock have entered into agreements with Bristol-Myers Squibb to support the transaction and to tender their shares in the offer.
"The acquisition of ZymoGenetics brings us full ownership of a promising investigational biologic that strengthens our very diversified Hepatitis C portfolio. Building on our leadership in virology, we are developing a strong portfolio to help patients with Hepatitis C," said Lamberto Andreotti, chief executive officer, Bristol-Myers Squibb. "In addition, ZymoGenetics brings proven capabilities with therapeutic proteins and revenue from a marketed specialty surgical biologic. This acquisition is another example of our strategic, targeted approach to business development."
"By joining forces with Bristol-Myers Squibb, we believe we will enhance the long-term potential of ZymoGenetics’ portfolio of assets, while providing a compelling valuation for our shareholders," said Douglas E. Williams, Ph.D., chief executive officer of ZymoGenetics. "Our collaboration with Bristol-Myers Squibb in the development of PEG-Interferon lambda has been extremely positive and it has given us an opportunity to fully appreciate their capabilities. We believe that this transaction will maximize the potential for our products and product candidates to make a meaningful difference for patients in need."
Shares of ZymoGenetics soared $4.50, more than 84% in extended trading.
Forest Laboratories, Inc. (NYSE: FRX) announced after the market close that the U.S. Food and Drug Administration’s (FDA) Anti-Infective Drugs Advisory Committee voted 21 – 0 in favor of approval of ceftaroline fosamil for the treatment of community acquired bacterial pneumonia (CABP) and voted 18 – 0 in favor of approval for complicated skin and skin structure infections (cSSSI).
Ceftaroline is a novel, bactericidal, broad-spectrum injectable cephalosporin shown in pre-clinical and clinical trials to have activity against both gram-positive pathogens, including methicillin-resistant Staphylococcus aureus (MRSA) and Streptococcus pneumoniae, and common gram-negative pathogens.
The committee’s recommendation will be considered by the FDA as it reviews the new drug application (NDA) for ceftaroline, which was based primarily on data from two Phase III trials in CABP – FOCUS I and FOCUS II – and two Phase 3 trials in cSSSI – CANVAS I and CANVAS II. Forest anticipates action by the FDA during the fourth calendar quarter.
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) moved higher after the bell as the company announced that 65% of people overall achieved a sustained viral response (SVR or viral cure) with a telaprevir-based regimen in the pivotal Phase 3 REALIZE study, as compared to 17% of people in the control arm who received pegylated-interferon and ribavirin alone. REALIZE enrolled three groups of patients with genotype 1 hepatitis C who had undergone at least one prior treatment course with pegylated-interferon and ribavirin but did not achieve SVR: (1) those who relapsed, (2) those who achieved a partial response and (3) those who had almost no response, known as a null response. REALIZE is the only Phase 3 hepatitis C study to date of an investigational direct-acting antiviral therapy that was designed to evaluate all major subgroups of people whose prior treatment was unsuccessful, including those who had a null response. The safety and tolerability results were consistent with results from the other two Phase 3 studies of telaprevir. The REALIZE study was conducted by Vertex’s collaborator, Tibotec.
Watson Pharmaceuticals, Inc. (NYSE:WPI), after the bell today announced that its subsidiary, Watson Laboratories, Inc., has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Zarah (drospirenone and ethinyl estradiol tablets) 3 mg/0.03 mg, the generic equivalent to Bayer's Yasmin®. Watson has begun shipping the product. Bayer's lawsuit against Watson alleging that Watson's product infringes Bayer's U.S. Patent No. 5,569,652 remains pending in the U.S. District Court for the Southern District of New York.
Yasmin® and its generic equivalents had total U.S. sales of approximately $97 million for the twelve months ending June 30, 2010, according to IMS Health. Watson's Zarah™ tablets are indicated for the prevention of pregnancy in women who elect to use an oral contraceptive.
In news from earlier in the day:
Idenix Pharmaceuticals, Inc. (Nasdaq:IDIX), a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today announced that the company received verbal notice on Friday, September 3, 2010 from the U.S. Food and Drug Administration (FDA) that the IDX184 and IDX320 programs have been placed on clinical hold. A clinical hold is an order issued by the FDA to the sponsor to delay a proposed clinical investigation or to suspend an ongoing investigation. This decision was made after Idenix notified the FDA of three serious adverse events that occurred during a drug-drug interaction study of the combination of IDX184 and IDX320 in healthy volunteers. These observed serious adverse events were elevated liver function tests detected in three subjects during post exposure safety visits. The liver function tests have returned to nearly normal levels in all three subjects during follow-up. All planned studies of IDX184 and IDX320 to date have been completed and there are currently no healthy volunteers or patients receiving IDX184 or IDX320. Idenix will submit full data to the FDA from recently completed preclinical and clinical studies, including 3-month chronic toxicology studies of IDX184, a 14-day study of IDX184 in combination with pegylated interferon/ribavirin (PegIFN/RBV), a 3-day proof-of-concept study of IDX320 in hepatitis C (HCV) infected patients, and the IDX184 and IDX320 drug-drug interaction study in healthy volunteers in order to assess next steps in the development of both compounds.
"We have not yet received a formal letter from the FDA, nor has the Agency had an opportunity to review the safety and efficacy data from recently completed clinical trials with IDX184 and IDX320. Based upon our discussions with the Agency, we are primarily focused on three cases of elevated liver function tests observed during our drug-drug interaction study of the combination of IDX184 and IDX320 in healthy volunteers," said Jean-Pierre Sommadossi, Ph.D., Idenix Chairman and Chief Executive Officer. "Based upon the safety and antiviral activity we observed in the IDX184 14-day study and the IDX320 3-day proof-of-concept study, both in HCV-infected patients, we remain committed to the future potential of these drug candidates. We will work closely with independent experts and our external safety committee to better understand the cause of these serious adverse events in the combination study of IDX184 and IDX320 and to provide the FDA with more information in order to expedite their review and resolve this matter as quickly as possible."
Full data presentations of IDX184, IDX320 and IDX375 studies will be presented at the annual meeting of the American Association for the Study of Liver Diseases (AASLD), which will be held at the end of October in Boston.
Shares of Idenix fell $2.81 or 46.91% to close at $3.18.
Rexahn Pharmaceuticals, Inc. (NYSE Amex: RNN), a clinical stage pharmaceutical company developing and commercializing potential best in class oncology and CNS therapeutics, today announced that it has submitted a Phase IIb protocol to the U.S. Food and Drug Administration (FDA) for the clinical study of Serdaxin for the treatment of major depressive disorder (MDD).
The Phase IIb study will assess Serdaxin’s efficacy as a treatment for major depressive disorder in approximately 300 subjects. The planned double blind, randomized, placebo-controlled trial will be conducted at multiple sites in the U.S. and will measure the change from baseline on the Montgomery-Asberg Depression Rating Scale (MADRS) as the primary efficacy endpoint.
"We look forward to starting this Phase IIb clinical trial and further investigating how Serdaxin’s novel action as a dual serotonin and dopamine enhancer may be able to provide a broader therapeutic effect with fewer side effects compared to currently marketed antidepressants," said Dr. Chang Ahn, Rexahn’s Chief Executive Officer.
In recent comments made about the promise of Serdaxin, Dr. Michael Thase, Professor of Psychiatry and Chief of the Division of Mood and Anxiety Disorders Treatment and Research Program at the University of Pennsylvania and Chairman of Rexahn’s scientific advisory board in MDD, said, "In my opinion, Serdaxin’s novel mechanism, which targets both serotonin and dopamine, coupled with the promising results of the recent proof of concept study, provide strong support for further clinical development of this well tolerated drug for treatment of depression."
NeoStem, Inc. (NYSE Amex: NBS) today announced that it has appointed Ian Zhang, Ph.D., MBA, as the new president and managing director of NeoStem (China), Inc. Dr. Zhang is the former Head of Asia Pacific Integration at Life Technologies, where he served on the steering committee managing the acquisition and integration of Applied BioSystems. He is also the former Head of Corporate Development (Asia Pacific) for Invitrogen responsible for growth strategy and acquisitions and integrations, where he had also managed the acquisition and integration of BioAsia, Dynal, Zymed, and Caltech by Invitrogen. Dr. Zhang also served as the President and General Manager for Dynal Biotech (Beijing) Ltd. (a wholly owned subsidiary of Invitrogen Corporation).
Cerus Corporation (NASDAQ:CERS) and Whittemore Peterson Institute for Neuro-Immune Disease (WPI) presented data at today's NIH-sponsored 1st International Workshop on XMRV which demonstrates the efficacy of Cerus' INTERCEPT Blood System to inactivate XMRV and other MLV-related viruses in donated blood. Recent scientific studies have detected these human retroviruses in up to seven percent of healthy blood donor samples, indicating approximately 20 million people in the United States could unknowingly be carrying the infection. XMRV and MLV-related viruses have been linked to prostate cancer and myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS).
"The genetic variability of XMRV and MLV-related viruses will make development of screening assays for the blood supply challenging," said Dr. Judy Mikovits, director of research at WPI and lead author of the study. "The INTERCEPT technology demonstrates robust inactivation of these viruses and holds promise as a potential proactive approach to mitigating the risk of XMLV/MLV-related virus transmission via transfusion."
CytRx Corporation (Nasdaq:CYTR), a biopharmaceutical company specializing in oncology, today announced initiation of the PROstate Advanced Cancer Treatment (PROACT) Phase 2 proof-of-concept clinical trial to evaluate the efficacy and safety of bafetinib in patients with advanced prostate cancer.
The open-label PROACT trial is being conducted at City of Hope, located just outside of Los Angeles, California, as well as multiple clinical sites in India. In the trial, approximately 50 patients with metastatic hormone-refractory prostate cancer who have failed first-line therapy with chemotherapy will receive orally available bafetinib twice daily. The trial endpoints are reduction in prostate-specific antibodies and increases in progression-free survival compared to baseline and historical data.
Generex Biotechnology Corporation (Nasdaq:GNBT), the leader in drug delivery for metabolic diseases through the inner lining of the mouth, today announced that it has entered into a long-term marketing and distribution agreement with Merck, S.A. de C.V. in Mexico for the distribution of one of the Company's proprietary over-the-counter products, Glucose RapidSpray brand formulated glucose spray product. Merck will market and distribute the product in Mexico as Diabion® GlucoShot®.
Intellect Neurosciences, Inc. (OTCBB:ILNS), announced that it has engaged Dr. Giora Feuerstein as a key consultant to advise the Company regarding its technology programs and pipeline. Until earlier this year, Dr. Feuerstein was Assistant Vice President & Head, Discovery Translational Medicine at Pfizer, having previously held these positions at Wyeth Research. Dr. Feuerstein resigned his position at Pfizer to focus on applying his expertise to assist smaller biopharmaceutical companies in meeting their drug development objectives via effective translational medicine strategies.
Dr. Daniel Chain, Chairman and Chief Executive Officer of Intellect, commented: "We are privileged and absolutely delighted that Dr. Feuerstein has taken an active interest in Intellect Neurosciences. Dr. Feuerstein's breadth and scope of experience in guiding biopharmaceutical research and translational medicine is simply unparalleled in the industry. Dr. Feuerstein is widely credited in relation to the extraordinary cardiovascular and neuroscience pipeline at Wyeth that drove the acquisition by Pfizer last year. His agreement to provide consulting services to Intellect brings a phenomenal set of skills to help the Company in its endeavors to develop innovative and safe disease-modifying drugs for the treatment of Alzheimer's disease and other serious conditions."
Dr. Feuerstein commented: "I am pleased to be able to contribute my knowledge and expertise to help Intellect Neurosciences, which has an exciting pipeline and abundance of innovative ideas to develop new biopharmaceutical products. Dr. Chain impressed me by his critical, objective and balanced scientific assessments that I personally appreciate and like. I am confident that, under this type of leadership, the Company will meet its important objectives focused on the development of innovative drugs that will provide meaningful medical benefits via disease-modifying mechanisms along with maximum safety."
RevMed (OTCBB:RMCP) has secured a binding 5 Year contract to produce 5M syringes/month of its 3mL fixed needle safety syringe with Medical Investment Group, LLC (MIG). MIG, a Massachusetts Limited Liability Company, will fulfill this obligation through its relationship with an internationally certified global medical device manufacturer. The manufacturer currently ships medical products throughout the world and is compliant with all major international standards including FDA, CE and Health Canada as well as those required in Japan, China and India. The factory is fully ISO compliant for medical device manufacturing and has comprehensive clean rooms, packaging and sterilization facilities. The factory has a current capability to scale up to 20 - 50 million syringes per month if required. First shipments for delivery are currently expected at the end of Q1/2011.
Somaxon Pharmaceuticals, Inc. (Nasdaq: SOMX), a specialty pharmaceutical company, today announced that Silenor® (doxepin) now is commercially available by prescription in the United States. Somaxon has implemented a wholesale and retail stocking program to disseminate Silenor 3 mg and 6 mg dosepacks to pharmacies across the United States. Silenor is indicated for the treatment of insomnia characterized by difficulty with sleep maintenance.
"The commercial availability of Silenor, the first and only prescription product approved for the treatment of sleep maintenance insomnia that is not a controlled substance, is an important milestone for Somaxon and marks the completion of our product launch preparations," said Richard W. Pascoe, Somaxon’s President and Chief Executive Officer. "We look forward to promoting this highly differentiated product to healthcare providers alongside our co-promotion partner, Procter & Gamble. Our combined sales teams will begin full-scale, field-based promotion of the product on September 20, 2010, targeting approximately 35,000 physicians and 25,000 pharmacies across the U.S."
"In conjunction with the deployment of our field-based promotion to healthcare providers, we will launch a comprehensive marketing program that will utilize web-based initiatives and will be directed at both physicians not called on directly by our sales force as well as patients suffering from sleep maintenance insomnia," continued Pascoe. "This campaign will highlight the traits that we believe will position Silenor for success in the insomnia market – the ability to treat sleep maintenance insomnia into the final hours of the night without meaningful next-day residual effects and without abuse potential."
St. Jude Medical, Inc. (NYSE: STJ), a global medical device company, and privately-held CardioMEMS today announced that they have reached an agreement under which St. Jude Medical will make a $60 million equity investment in CardioMEMS, a medical device company that has developed a wireless sensing and communication technology to assess cardiac performance. The agreement provides St. Jude Medical an immediate 19 percent ownership in CardioMEMS and the exclusive option to acquire the company for an additional payment of $375 million during the period that extends through the completion of certain commercialization milestones.
Teleflex Incorporated (NYSE:TFX) today announced that it has received 510(k) market clearance from the U.S. Food and Drug Administration (FDA) for the company’s ArrowEVOLUTION PICC with Chlorag+ard technology, a peripherally inserted central catheter with a Chlorhexedine-based solution that has been chemically-bonded into the surface of the catheter both intra- and extralumenally. Teleflex will launch the product for general availability in the United States in the fourth quarter.
3SBio Inc. ("3SBio") (Nasdaq:SSRX), a leading China-based biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products today announced its planned participation in the following investor conferences: Sep 9-10, 2010 Susquehanna Fourth Annual Beijing Management Summit Beijing Sep 13-14, 2010
Oragenics, Inc. (OTCBB: ORNI) announced today that its oral care probiotic EvoraPlus® is now expected to be available at corporate-owned GNC stores nationwide.
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