(RX) Big Pharma and Biotech – Industry Outlook

On 7/22/09, Schering-Plough (NYSE:SGP) announced that a New Drug Application (NDA) for a fixed-dose combination of mometasone furoate and formoterol fumarate was filed and accepted for review by the FDA. The NDA is seeking marketing approval from the FDA for the maintenance treatment of asthma in patients 12 years of age and older. This new product combines the active ingredients of already-approved and marketed single-agent products which include an inhaled corticosteroid (Asmanex -mometasone furoate inhalation powder) and a long-acting beta2-agonist (Foradil - formoterol fumarate inhalation powder), administered via a single metered-dose inhaler. SGP has exclusive worldwide rights for the development and commercialization of the mometasone furoate and formoterol furmarate fixed-dose combination and is in the process of being acquired by Merck (NYSE:MRK).

On 7/22/09, Hemispherx Biopharma (AMEX:HEB) provided guidance that it does not expect a FDA decision on its Ampligen New Drug Application (NDA) until fall 2009. President/CEO Dr. William Carter said staffing problems at the FDA this year have resulted in the agency missing deadlines for final decisions on nearly two-thirds of NDAs under review. During a 7/22 conference call, Dr. Carter said HEB has been in contact with the FDA since May, has been regularly providing reports to different reviewers, and does not believe any additional documentation will be required by the Agency. Ampligen (Poly I: Poly C12U) is an experimental treatment for chronic fatigue syndrome (which has no FDA-approved treatments) with Orphan Drug Status.

On 7/22/09, Human Genome Sciences (NASDAQ:HGSI) reported its quarterly results and stated that the Company and Novartis (NYSE:NVS) have completed pre-submission meetings with the FDA and EMEA regarding Zalbin (albinterferon-alfa 2b, formerly Albuferon) with planned submissions for global regulatory marketing approvals on track for fall 2009 seeking treatment of hepatitis C (HCV) types 2 or 3 viral infection. In April 2009, positive Phase 3 results for Zalbin in patients with chronic hepatitis C were presented at a medical conference and data from two pivotal Phase 3 trials, ACHIEVE 1 and ACHIEVE 2/3, showed that Zalbin met its primary endpoint of non-inferiority to Pegasys (peginterferon alfa-2a). With half the injections, Zalbin achieved a rate of sustained virologic response comparable to Pegasys in these studies and comparable safety results.

On 7/22/09, Bovie Medical (AMEX:BVX) announced a 510(k) submission to the FDA seeking pre-market clearance for the Company's Polarian Seal-N-Cut vessel sealing line of hybrid monopolar and bipolar forceps. The new Seal-N-Cut line of instruments provides for monopolar and bipolar energy combined with intelligent feedback from Bovie's Hybrid VS electrosurgical generator. The Seal-N-Cut devices also accommodate a wide array of possible applications in either monopolar or bipolar surgeries thereby serving endoscopic needs in multiple endoscopic fields including Endo GYN, General Surgery, Pediatric surgery, Thoracic Endoscopy and Urology. Bipolar vessel sealing and coagulation is one of the fastest growing markets in Endoscopy, estimated to exceed $1 billion in revenues worldwide.

On 7/22/09, Bayer (BAYRY.PK) and Onyx Pharma (NASDAQ:ONXX) announced that their first cooperative group-sponsored randomized Phase 2 trial in advanced metastatic breast cancer met its primary endpoint of progression-free survival. The study evaluated Nexavar (sorafenib) tablets in combination with the oral chemotherapeutic, capecitabine, in patients with locally advanced or metastatic HER-2 negative breast cancer. Study findings demonstrated that the median progression-free survival was extended in patients treated with Nexavar and capecitabine compared to patients receiving capecitabine and placebo. These results were statistically significant (p = .0006). In this trial, the safety and tolerability of the combination was as expected and did not show any new or unexpected toxicities. A complete data analysis from this study is expected to be presented at an upcoming scientific meeting. Onyx and Bayer are currently evaluating various strategies for Nexavar in breast cancer.

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On 2/20/09, Schering-Plough (NYSE:SGP) resubmitted its Saphris (asenapine) sublingual tablets NDA in response to the FDA's complete response letter from January 2009 for the acute treatment of schizophrenia in adults and for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults as monotherapy. An FDA Advisory Panel meeting is scheduled for 7/30/09 and SGP is in the process of being acquired by Merck (NYSE:MRK). In briefing documents posted online, the Agency's director of psychiatry products Thomas Laughren stated, "we generally are in agreement that the sponsor has provided adequate support to suggest effectiveness," and also that the drug's safety profile was "acceptable" and appears to be "qualitatively similar to that observed for other atypical antipsychotic drugs."

On 7/28/09, Shire (NASDAQ:SHPGY) announced that it received a Complete Response Letter (CRL) for Intuniv (guanfacine) Extended Release from the FDA. This decision comes following labeling discussions with the FDA that did not result in agreement in time to meet the PDUFA date. The FDA did not identify safety concerns regarding Intuniv in the CRL or request new clinical studies. Shire and the FDA will continue to work together to resolve the remaining labeling language over the next 4-8 weeks. Shire stated in the PR that the Company is confident on quickly reaching an agreement on the final product label and anticipates a launch during 4Q09 for Intuniv.

On 7/28/09, Elron Electronic Industries (NASDAQ:ELRN) announced that Medingo Ltd., a group company held 92% by Elron and its subsidiary RDC - Rafael Development Corporation Ltd., has received an informal notice, by electronic mail, that the FDA has granted clearance to market its Solo MicroPump Insulin Delivery System in the United States. A formal and detailed letter from the FDA has not yet been received, and Elron will issue an immediate release once a formal letter is received from the Agency.

On 7/28/09, Cardium Therapeutics (AMEX:CXM) and its subsidiary Tissue Repair Company (TRC) provided an update on the completion of their MATRIX Phase 2b clinical study and announced plans to provide detailed safety and efficacy data for their Excellarate product candidate around the end of September. The MATRIX trial, a prospective, randomized, double-blind, placebo-controlled study, has enrolled 124 diabetic patients with non-healing, lower extremity neuropathic ulcers. The companies also reported that results from the MATRIX clinical study are expected to be used to support additional studies and applications of Tissue Repair's Gene Activated Matrix (GAM) technology for ulcers and other potential applications, including not only the repair of soft tissue injuries such as diabetic or pressure ulcers, but hard tissue injuries such as those affecting bone.

Additional information regarding the use of Excellarate for the potential treatment of diabetic foot ulcers and other potential GAM product candidates is expected to be reported over the next several weeks and months. CXM stated that more than 90% of the patients enrolled into the MATRIX study have now completed their initial 12-week evaluation period with respect to key safety and efficacy criteria. While the efficacy data from the MATRIX study remains blinded as final patients advance through the 12-week evaluation period, there continues to be no safety concerns since announcement of completion of patient recruitment in May 2009.

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