KBIO In Detox Mode, CTIC Abuzz, MYL Does Damage Control, D-Day For RIGL

(RTTNews) - Amgen Inc.'s (AMGN) phase III study of Prolia in patients receiving glucocorticoid therapy has met all primary and secondary endpoints at 12 months.

According to the study results, Prolia led to significantly greater gains in bone mineral density (BMD) at the lumbar spine and total hip, both in patients receiving continuing glucocorticoid therapy and in patients newly initiating glucocorticoid therapy.

Glucocorticoid medicines, which are commonly used to treat inflammatory diseases, increase the risk of fracture by up to 75 percent, although BMD will continue to decline significantly in the months to follow.

Prolia received its first FDA approval in June 2010 for the treatment of postmenopausal women with osteoporosis at high risk for fracture, and in September 2011 for the treatment of bone loss in patients with prostate or breast cancer undergoing hormone ablation therapy, and in September 2012 to increase bone mass in men with osteoporosis at high risk for fracture.

AMGN closed Monday's trading at $171.51, down 0.27%.

CTI BioPharma Corp.'s (CTIC) phase III trial of Pacritinib for high-risk patients with advanced myelofibrosis has met one of the co-primary endpoints and has failed to achieve another.

One of the most common and debilitating symptoms of myelofibrosis is spleen enlargement (splenomegaly).

The trial, dubbed PERSIST-2, has demonstrated statistically significant improvement in spleen volume reduction with Pacritinib compared to best available therapy (BAT), including Ruxolitinib. However, the other co-primary endpoint of greater than 50 percent reduction in Total Symptom Score (TSS) was not met.

CTIC closed Monday's trading at $0.40, up 14.86%.

Elite Pharmaceuticals Inc. (ELTP.OB) has entered into a Development and License Agreement with SunGen Pharma LLC to collaborate to develop and commercialize four generic pharmaceutical products.

The developmental costs of the 4 products will be shared by Elite and SunGen and will be owned jointly by them. SunGen shall have the exclusive right to market and sell two of the products using SunGen's label and Elite shall have the exclusive right to market and sell two of the products using Elite's label. Elite will manufacture and package all four products on a cost plus basis, according to the agreement terms.

ELTP.OB soared 14.57% on Monday to close the day's trading at $0.19.

Martin Shkreli, who made headlines last fall for wrong reasons, has sold his remaining shares of KaloBios Pharmaceuticals Inc. (KBIO) common stock, fully eliminating his association with the company.

Last November, an investor group comprised of Martin Shkreli and associates together acquired 70% of the outstanding shares of KaloBios, and Shkreli was appointed CEO of the company. The following month, Shkreli was arrested by the FBI on charges of securities fraud at his former hedge fund. He was removed as CEO from KaloBios, following his arrest.

In July of this year, KaloBios entered into an agreement with Martin Shkreli, regarding his ownership of the company's common stock, reducing his ownership to about 14%. Now that he has sold his remaining stake too, Shkreli has zero ownership of the capital stock of, or ongoing financial interest in, KaloBios.

Martin Shkreli made headlines last August when Turing Pharmaceuticals AG, the company he headed, hiked the price of an antibiotic Daraprim from $13.50 a pill to $750 a pill.

KBIO closed Monday's trading 5.43% higher at $3.69.

Mylan N.V. (MYL), which has come in for sharp criticism for hiking the price of EpiPen by 400% in nine years, has apparently started to take some damage control measures.

Accordingly, the company's U.S. subsidiary will launch the first generic to EpiPen Auto-Injector at a list price of $300 per generic EpiPen two-pack carton, which represents a discount of more than 50% to the Mylan list price, or wholesale acquisition cost of the branded medicine.

EpiPen and EpiPen Jr Auto-Injectors are used for the emergency treatment of life-threatening allergic reactions.

MYL closed Monday's trading at $43.22, up 0.44%.

Nymox Pharmaceutical Corp.'s (NYMX) lead drug candidate Fexapotide for prostate enlargement and for low grade prostate cancer has produced some promising results in a phase III long-term study.

According to the study results, Fexapotide not only showed clinically meaningful and durable relief of BPH (benign prostatic hyperplasia) symptoms in men with prostate enlargement, but also showed a major reduction in the incidence of prostate cancer, compared to placebo and compared to the known and expected normal incidence of the disease.

Fexapotide will be filed for approval in the next 1-2 quarters.

NYMX closed Monday's trading at $3.95, up 5.90%.

Rigel Pharmaceuticals Inc. (RIGL) will be announcing the results of the first of two phase III studies of Fostamatinib for patients with immune thrombocytopenia at 7:00 a.m. Eastern Time on Tuesday, August 30, 2016.

Immune thrombocytopenia, or ITP, is a condition where the immune system attacks and destroys the body's own blood platelets, which play an active role in blood clotting and healing. ITP patients can suffer extraordinary bruising, bleeding and fatigue as a result of low platelet counts.

The phase III program of Fostamatinib consists of two identical studies of approximately 75 patients each. The primary efficacy endpoint of this program is a stable platelet response by week 24 with platelet counts at or above 50,000 per microliter of blood for at least four of the final six qualifying blood draws.

RIGL closed Monday's trading at $2.64, up 1.15%.