ACHN Cuts A Deal For HCV Assets, LuViva Snubbed Again, Medidur Proves Safe

(RTTNews) - Achillion Pharmaceuticals Inc. (ACHN) has entered into a worldwide license and collaboration arrangement with Janssen Pharmaceuticals Inc., a subsidiary of Johnson & Johnson (JNJ), to develop and commercialize one or more of Achillion's lead hepatitis C virus assets which include ACH-3102, ACH-3422, and Sovaprevir.

The collaboration focuses on the development of a short-duration, highly effective, pan-genotypic, oral regimen for the treatment of hepatitis C virus, or HCV.

An initial regimen that will be explored will feature Achillion's ACH-3102, a second-generation NS5A inhibitor currently in phase 2 clinical studies in combination with an NS3/4A HCV protease inhibitor plus an NS5B HCV polymerase inhibitor from the collaboration. Achillion is eligible to receive about $1.1 billion in potential development, regulatory and sales milestone payments under the collaboration.

Additionally, Johnson & Johnson Innovation - JJDC, Inc. will invest $225 million in Achillion and, in return, receive about 18.4 million newly issued, unregistered shares of Achillion at a price of $12.25 per share.

ACHN closed Tuesday's trading at $10.68, down 3.17%.

Derma Sciences Inc. (DSCI) is aiming to complete enrollment in its phase III program with Aclerastide in subjects with diabetic foot ulcers by the end of June 2016.

The company noted that database lock will occur within a couple of months after the last subjects complete the 24 weeks of study participation, and that top-line results should be available within a few weeks after database lock.

DSCI closed Tuesday's trading at $6.84, down 2.29%.

Guided Therapeutics Inc.'s (GTHP.OB) amended pre-market approval application for LuViva Advanced Cervical Scan has failed to pass muster with the FDA again.

LuViva Advanced Cervical Scan is a medical device that noninvasively measures cervical tissue using hyper-spectroscopic technology for use in a population of women identified as being at risk for cervical cancer by abnormal cytology (Pap), human papillomavirus (HPV) test or previous cervical disease.

The FDA, which completed the review of the company's amended PMA filed last July, has ruled that the application is not approvable in its current form.

While the regulatory agency has noted that more patient data would likely be necessary to amend the current application, it has also stated its willingness to consider alternative approaches to move the product to approvable form.

The company currently has regulatory approval to sell LuViva in Europe with the Edition 3 CE mark, and has marketing approvals from COFEPRIS in Mexico, Health Canada and Singapore Health Sciences Authority, among others. Additionally, expansion efforts are ongoing in the Middle East, Asia and Latin America.

GTHP.OB closed Tuesday's trading at $0.16, down 3%.

GlycoMimetics Inc. (GLYC) has initiated a phase 1/2 clinical study of GMI-1271 in combination with chemotherapy in patients with acute myeloid leukemia (AML). The study will enroll approximately 77 subjects.

GMI-1271 has FDA's Orphan Drug designation for treatment of AML.

GLYC closed Tuesday's trading at $8.59, down 0.35%.

Intercept Pharmaceuticals Inc. (ICPT) plans to initiate an international phase III trial of obeticholic acid (OCA), the company's lead FXR agonist, in patients with non-cirrhotic nonalcoholic steatohepatitis, or NASH, with liver fibrosis in the third quarter of 2015.

The trial, dubbed REGENERATE, is expected to enroll up to approximately 2,500 patients, and will be conducted at approximately 250 centers in North America, Europe and other regions.

The company had cash of roughly $402.0 million at March 31, 2015.

ICPT closed Tuesday's trading at $263.50, down 16.08%.

pSivida Corp.'s (PSDV) lead product candidate, Medidur, for posterior uveitis, a blinding eye disease, has demonstrated encouraging safety profile in its first phase III study. The study completed the targeted enrollment of 120 patients in March of this year, and top line results are expected to be available in Q2 2016.

The company recently initiated a second phase III trial of Medidur, which will enroll up to 150 patients in India. psivida intends to file for U.S. approval of of Medidur for posterior uveitis in the first half of 2017.

PSDV closed Tuesday's trading at $4.10, up 2.76%.