BIOD To Report Data Next Month, HALO Shines On Deal News, TTPH Gets Ignited

(RTTNews) - Biodel Inc. (BIOD) is slated to report top line data from a phase 2a clinical trial of its proprietary concentrated insulin formulation BIOD-531 in patients with type 2 diabetes with severe insulin resistance early next month.

The trial, dubbed Study 3-151, compares BIOD-531 to Humalog Mix 75/25 and Humulin R U-500.

A phase I proof-of-concept clinical trial of the company's lyophilized glucagon formulation designed for use in a proprietary auto-reconstitution device intended for the rescue of patients with severe hypoglycemia is underway, and top-line results are expected in the first half of 2015.

BIOD closed Wednesday's trading at $1.33, up 2.31%.

Halozyme Therapeutics Inc. (HALO) has entered into a worldwide Collaboration and License Agreement, worth $581 million, with Janssen Biotech Inc., a unit of Johnson & Johnson (JNJ), to develop and commercialize subcutaneous products using ENHANZE technology.

ENHANZE is Halozyme's proprietary drug delivery platform based on the company's patented recombinant human hyaluronidase enzyme (rHuPH20).

As per the terms of the agreement, Halozyme has granted Janssen a worldwide license to develop and commercialize products for up to five targets combining rHuPH20 with Janssen's proprietary compounds.

The deal enables Halozyme to receive an initial payment of $15 million and additional payments totaling up to $566 million upon Janssen's achievement of specified development, regulatory and sales-based milestones. Halozyme is also entitled to royalty payments from Janssen based on net sales of products using the ENHANZE technology.

HALO closed Wednesday's trading 13.22% higher at $8.65.

Pfizer Inc. (PFE) has initiated a multicenter phase II clinical trial of its investigational compound PF-06252616 in boys with Duchenne muscular dystrophy.

Duchenne Muscular Dystrophy, or DMD, the most common form of muscular dystrophy, is a genetic disorder caused by a mutation in a gene that can code for a protein in the muscles called dystrophin. This disorder is terminal, and death usually occurs before the age of 30 for the patients.

DMD, which is characterized by muscle weakness and calf enlargement, affects mostly boys, with 1 in every 3,500 boys worldwide being born with this disease. It is estimated that there are roughly 30,000 DMD patients in the U.S., EU and Japan.

Currently, there are no FDA-approved therapies for DMD. Prosensa Holding N.V., PTC Therapeutics Inc. and Sarepta Therapeutics Inc. are some of the other companies working towards finding a cure for DMD.

PFE closed Wednesday's trading 1.47% higher at $31.12.

POZEN Inc. (POZN) has been sent back to the drawing board for the second time, with the FDA issuing a Complete Response Letter again for the company's investigational drug candidates YOSPRALA 81/40 and 325/40 for the secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers.

This time too, the regulatory agency has raised the issue of deficiencies in the foreign manufacturing facility of an active ingredient supplier in the complete response Letter, or CRL. However there are clinical or safety deficiencies with respect to either YOSPRALA 81/40 or YOSPRALA 325/40, the company noted.

POZN closed Wednesday's trading at $8.10, down 10.30%.

Quidel Corp.'s (QDEL) Sofia Strep A+ Fluorescent Immunoassay for the rapid detection of infections by Group A Streptococcus bacteria has received marketing clearance and CLIA waiver from the FDA. Group A Streptococcus bacteria are the most common cause of bacterial pharyngitis, rheumatic fever and other potentially serious illnesses.

The company thus becomes the first to receive joint clearance and CLIA waiver designation under the regulatory agency's new Dual Submission Program, allowing it to sell the assay to all CLIA categories of laboratories in the U.S., including the CLIA-waived segment of the market that is comprised of about 30,000 physician offices laboratories and 5,000 hospital emergency departments.

The FDA's new Dual Submission Program requires a Pre-submission, and allows for simultaneous review of the 510(k) and CLIA waiver applications, substantially reducing the time and effort required for the FDA's review of 510(k) and CLIA waiver submissions that previously required two independent sequential submissions.

QDEL closed Wednesday's trading at $26.58, up 4.93%.

Tetraphase Pharmaceuticals Inc.'s (TTPH) first of the two pivotal trials, dubbed IGNITE 1, evaluating its drug candidate Eravacycline for the treatment of complicated intra-abdominal infection has achieved the primary endpoint of statistical non-inferiority.

IGNITE 1, a phase III clinical trial, compared Eravacycline to approved antibiotic Ertapenem in complicated Intra-abdominal Infections.

Another phase III trial of Eravacycline, known as IGNITE 2, is ongoing in complicated urinary tract infections (cUTI), and results from this trial are expected in mid-2015.

TTPH closed Wednesday's trading 10.56% higher at $33.19. In after-hours, the stock was up another 14.52% at $38.01.