BPMX Scores A Facelift, MDVN Says "I Do" To PFE, Europe Gets Its 1st HIV PrEP

Pharma 082316

Shares of BioPharmX Corp. (BPMX) climbed more than 15% on Monday, following positive findings from the company's phase 2a safety study of BPX-01 in facial Propionibacterium acnes.

According to the trial results, the topical gel formulation of BPX-01 reduced facial P. acnes by over 90% in four weeks - a statistically significant advantage over the study's control vehicle.

The American Academy of Dermatology calls acne the "most common skin condition in the United States," affecting 40 to 50 million Americans. The U.S. market for acne medications is estimated at $10 billion.

BPMX closed Monday's trading at $0.90, up 15.38%.

The European Commission has granted marketing authorization for Gilead Inc.'s (GILD) once-daily Truvada in combination with safer-sex practices to reduce the risk of sexually acquired HIV-1 infection among uninfected adults at high risk, a strategy known as pre-exposure prophylaxis, or PrEP. The drug was approved by the FDA for this indication in 2012.

In addition to the European Union and U.S., Truvada is authorized for PrEP in Australia, Canada, Kenya, Peru and South Africa.

Truvada in combination with other antiretroviral agents for the treatment of HIV-1 infection was approved by the EMA in 2005 and by the FDA in 2004. The drug notched sales of $3.46 billion in 2015, up 3.6% over the prior year.

GILD closed Monday's trading at $80.92, down 0.10%.

Pfizer Inc. (PFE) is all set to acquire Medivation Inc. (MDVN) for $81.50 a share in cash for a total enterprise value of approximately $14 billion.

The merger is expected to be immediately accretive to Pfizer's Adjusted Diluted EPS upon closing, approximately $0.05 accretive in the first full year after close with additional accretion and growth anticipated thereafter.

The acquisition adds Xtandi, Medivation's key drug, which is approved for use in prostate cancer, to Pfizer's portfolio. Global sales of Xtandi in 2015 came in at $1.9 billion, up 80% over the prior year.

Sanofi has also been eyeing Medivation for quite some time, and in March of this year, had made an unsolicited offer of $9.3 billion to acquire it, which was outrightly rejected.

PFE closed Monday's trading at $34.84, down 0.40%. MDVN closed the day's trading 19.74% higher at $80.42.

Regeneron Pharmaceuticals Inc. (REGN) has entered into an agreement with the Biomedical Advanced Research and Development Authority of the U.S. Department of Health and Human Services to manufacture and study two antibody therapies for the potential prevention and treatment of Middle East Respiratory Syndrome.

The company will receive a funding of up to $8.9 million from the U.S. Department of Health and Human Services for packaging and labeling of the antibodies for human use, the preparation and submission of an Investigational New Drug application with the FDA , and a National Institutes of Health-conducted clinical trial in healthy volunteers.

REGN closed Monday's trading at $418.65, up 3.55%.

Versartis Inc. (VSAR) has completed enrollment in its phase III trial of Somavaratan in pediatric growth hormone deficiency.

The trial, dubbed VELOCITY, is designed to evaluate the primary trial endpoint of height velocity at 12 months, as well as safety and pharmacodynamic secondary endpoints. Top-line results are anticipated in Q3 2017.

A phase II trial of Somavaratan in adult growth hormone deficiency, dubbed VITAL, is underway, with top-line results expected during the second half of 2016.

VSAR closed Monday's trading at $13.09, up 1.39%.

VBI Vaccines Inc. (VBIV) (VBV.TO) has been allowed to continue with the enrollment of participants across all sites and dose groups in the Phase I clinical study to evaluate its preventative cytomegalovirus vaccine candidate, following a review by the Data Safety Monitoring Board.

The phase I trial is expected to last 20 months, and preliminary results are anticipated in the first half of 2017.

VBIV closed Monday's trading at $3.75, up 5.34%.

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