The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA deadline dates. The entries are updated on a daily basis as new information becomes available with a total of 110 entries through 4/1/09. The FDA Calendar includes the following information: company name, ticker, decision date, and description.
The Clinical Trial Calendar includes 136 entries through 4/1/09 and encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions to the FDA for complete response rulings by the agency which require more information before an approval can be granted.
1.) Sepracor (SEPR): On 4/1/09 SEPR filed a NDA with the FDA for the use of eslicarbazepine acetate as adjunctive therapy in the treatment of partial-onset seizures in adults with epilepsy. The proposed trade name for eslicarbazepine acetate is STEDESA.
STEDESA is a new chemical entity and is classified as a voltage-gated sodium channel blocker that has been designed to reduce the frequency of partial-onset seizures. Sepracor's NDA filing includes data from three Phase 3 studies in 1,000 patients from 23 countries. About 2.7 million people in the U.S. have epilepsy, representing a market opportunity of $3.5 billion. The PDUFA decision date deadline for a standard, 10-month review is 2/1/2010.
2.) Warner Chilcott (NASDAQ:WCRX): WCRX filed a NDA on 3/27/09 for FDA approval of WC-3016, a low-dose oral contraceptive with a PDUFA decision date deadline of 1/27/10 for a standard, 10-month review period.
3.) Wyeth (WYE) – Pfizer (NYSE:PFE): Wyeth submitted a BLA to the FDA on 3/31/09 for Prevnar 13, Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM(197) Protein). Last year, the FDA granted Prevnar 13 Fast Track designation (for an estimated six-month PDUFA date of 10/1/09).
Prevnar 13 is designed to protect against the 13 most prevalent serotypes associated with pneumococcal disease (PD), the leading cause of vaccine-preventable death worldwide. Seven of these serotypes (4, 6B, 9V, 14, 18C, 19F and 23F) are included in Prevnar®, Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM(197) Protein) - the current global standard in PD prevention in infants and young children. The six additional serotypes (1, 3, 5, 6A, 7F and 19A) are associated with the greatest remaining burden of invasive disease.
4.) GlaxoSmithKline (NYSE:GSK): GSK submitted two simultaneous regulatory applications on 4/1/09 to expand the use of TYVERB/TYKERB (lapatinib). The 10/1/09 estimated decision date is for a 6-month priority review of the cancer drug. If approved, TYVERB/TYKERB could be used as a first-line therapy regimen combined with anti-hormonal therapy for patients with hormone-sensitive, metastatic (or advanced) breast cancer in Europe and the United States.
The filings include data evaluating the combination of TYVERB/TYKERB plus an aromatase inhibitor based on a recent study which evaluated TYVERB/TYKERB in combination with letrozole in women whose breast cancer expressed was hormone receptor positive (HR+) and may or may not also over-expressed the HER2+/ErbB2+ receptor.
GSK also submitted final data to the FDA for CERVARIX®, its vaccine to prevent cervical cancer and cervical pre-cancer related to human papillomavirus types 16 and 18. GSK has submitted final data from its Phase III pivotal efficacy study, HPV-008, to the FDA on 3/30/09.
HPV-008 is a Phase 3 clinical study of more than 18,600 women between 15-25 years of age, from 14 countries across Europe, Asia-Pacific and Latin and North America. The BLA for the vaccine includes safety, efficacy and immune response data from clinical trials in nearly 30,000 females and reflects an ethnically diverse population.
To date, Glaxo's vaccine has been approved in more than 90 countries around the world including the 27 member countries of the European Union, Mexico, Australia, Singapore and the Philippines. Licensing applications have been submitted in more than 20 additional countries including Japan. GSK also submitted the vaccine to the World Health Organization (WHO) for prequalification in September 2007.
5.) Orthovita (NASDAQ:VITA): On 4/1/09, VITA submitted additional data to the FDA in support its 510(k) filing for the use of its CORTOSS Bone Augmentation Material in vertebral augmentation. This 510(k) application is intended to demonstrate that the performance of CORTOSS is substantially equivalent to polymethylmethacrylate (PMMA) bone cement. The data submitted today includes two-year follow-up data from Orthovita’s pivotal, prospective, randomized, multi-site clinical study conducted under an FDA investigational device exemption (NYSE:IDE).
In the pivotal study, a total of 162 patients were treated with CORTOSS and 94 patients were treated with PMMA. The two-year follow-up period has now been completed for the pivotal study. In addition to two-year follow-up clinical data for patients enrolled in the pivotal study, Orthovita has submitted to FDA data on patients from two pilot U.S. clinical investigations conducted under FDA IDEs and from several European studies with follow-up ranging from 11 months to over 4 years. The 10/1/09 decision date is a six-month review estimate since 510k applications do not have firm decision date deadlines or PDUFA dates.
6.) Acorda Therapeutics (NASDAQ:ACOR): Fampridine-SR Oral Tablet NDA to improve the walking ability of people with multiple sclerosis (NYSE:MS). On 3/31/09, the FDA refused to accept the NDA filing due to certain "format issues", delaying the drug's possible approval by a few months, but the agency is not requesting any additional clinical trials to be conducted.
7.) Roche (OTCQX:RHHBY): Avastin (bevacizumab) sBLA - brain cancer (relapsed glioblastoma) – PDUFA date of 5/5/09. Early data for Roche's drug Avastin shows enough promise in treating patients with a certain brain cancer to be considered for quick approval, a U.S. advisory panel said on Tuesday 3/31/09. The drugmaker is seeking accelerated approval to market the drug for patients diagnosed with a recurrence of the particularly deadly disease after trying other therapies first.
The drug, made by its recently acquired Genentech unit, is already used to treat lung, colon and breast cancers. Data from two early studies showed enough of a response in patients whose disease did not advance and some whose tumors decreased in size to warrant faster approval before the company finishes a larger trial to confirm the benefit, the panel said in a 10-0 vote.
8.) Arena Pharma (NASDAQ:ARNA): On 3/30/09, ARNA announced Phase 3 clinical trial results for its weight loss drug lorcaserin. While the results partly met FDA benchmarks, they still fell shy of a proposed FDA guideline that calls for at least a 5% point difference in weight loss between the test drug and placebo.
The average weight loss for lorcaserin patients was 5.8% (12.7 pounds) versus 2..2% (4.7 pounds) for patients receiving a placebo for a difference of 3.6%, which is shy of the FDA's 5% standard. Arena will announce additional Phase 3 data for lorcaserin in September and still expects to file for FDA approval by year-end based on positive safety data and meeting the study objectives for weight loss.
Earlier this year Orexigen Therapeutics (NASDAQ:OREX) experienced a similar stock price decline as ARNA as its experimental weight loss drug. Contrave fell shy of the same FDA benchmark (with a 4.2% incremental weight loss advantage over placebo) while meeting other study objectives. In June, Vivus (NASDAQ:VVUS) is expected to release Phase 3 clinical trial results for Qnexa, representing the third small-cap drug maker working to develop a prescription weight loss drug.
9.) Bristol-Myers (NYSE:BMY), Astra Zeneca (NYSE:AZN): Onglyza (saxagliptin oral tablets) NDA - A dipeptidyl peptidase-4 (DPP-4) enzyme inhibitor for Type 2 Diabetes -- PDUFA decision date deadline of 4/30/09. On 4/1/09, the FDA panel voted 10 to 2 that the companies' data rule out the risk that the drug hastens heart attack, stroke and other problems.
The only successful DPP-4 drug at present is Merck & Co's (NYSE:MRK) Januvia, which had sales of $1.4B in 2007. If approved, Onglyza could generate sales of more than $3B a year, according to some analysts, but most forecast sales of much less – around $200-400M.
On 4/2/09, a FDA Advisory Panel will review Novo Nordisk's (NYSE:NVO) Victoza, which belongs to the GLP-1 class of injectable drugs that stimulate insulin release only when glucose levels become too high. Consensus analyst estimates for Victoza sales are in the range of $1.3-1.5B.