BMRN Settles Lawsuit With Dr Reddy's, HRTX Gets FDA Date, TCON On Track

(RTTNews) - Amgen's (AMGN) supplemental New Drug Application seeking expanded labeling of Kyprolis in combination with dexamethasone for patients with relapsed multiple myeloma who have received at least one prior therapy has been accepted for priority review by the FDA. Accordingly, the FDA's decision is slated for January 22, 2016.

Kyprolis was first approved by the FDA in July 2012 to treat patients with multiple myeloma who have received at least two prior therapies, including treatment with Velcade (bortezomib) and an immunomodulatory therapy. In July of this year, the FDA approved Kyprolis in combination with Revlimid and dexamethasone for the treatment of patients with multiple myeloma who have received one to three prior lines of therapy.

Kyprolis raked in sales of $331 million in 2014.

AMGN closed Friday's trading at $15.059, down 2.16%.

BioMarin Pharmaceutical Inc. (BMRN), which had sued Dr. Reddy's Laboratories Inc. last November for infringing patents covering its phenylketonuria drug Kuvan, has agreed to resolve the patent litigation.

Under the terms of the settlement, BioMarin will grant Dr. Reddy's a non-exclusive license to its patents related to Kuvan to allow Dr. Reddy to market a generic version of the drug in the U.S. beginning at a confidential date in the future, but which is more than five years from today, or earlier under certain circumstances. Additional details of the agreement remain confidential.

BioMarin continues to vigorously enforce its intellectual property related to Kuvan. This includes continuing its suit against Par Pharmaceutical, Inc., which is not affected by this settlement.

Net product revenue from Kuvan was $203 million in 2014, and is expected to range between $210 million to $230 million in 2015.

BMRN closed Friday's trading at $130.65, down 1.12%.

Heron Therapeutics Inc.'s (HRTX) resubmitted New Drug Application for SUSTOL has been accepted for review by the FDA. The company is seeking approval of SUSTOL for the prevention of acute and delayed chemotherapy-induced nausea and vomiting associated with moderately emetogenic chemotherapy or highly emetogenic chemotherapy regimens.

The FDA's decision on SUSTOL is slated for January 17, 2016. This is SUSTOL's third go-around with the FDA as it was rejected by the regulatory agency twice - in 2013 and 2010.

HRTX closed Friday's trading 4.48% higher at $37.10.

Summit Therapeutics plc's (SMMT) new preclinical data on SMT19969, a novel and selective oral antibiotic for the treatment of Clostridium difficile infection, reveals that the drug candidate's selective antibiotic profile and potential to leave the healthy gut microbiome unharmed address the key clinical issue of disease recurrence.

The company is on track to report top-line data from its phase 2 proof of concept trial of SMT19969 during the fourth quarter of this year.

SMMT closed Friday's trading at $11.28, down 5.53%.

Shares of TRACON Pharmaceuticals (TCON) surged 36% on Friday after the company announced that complete response was observed in a choriocarcinoma patient treated with its drug candidate TRC105 in combination with Avastin in compassionate use phase II trial at Dana-Farber Cancer Institute.

Choriocarcinoma, an aggressive form of gestational trophoblastic neoplasia, represents the second orphan tumor type where durable complete responses have been observed with TRC105 combination treatment. In June 2015, Steven Attia of the Mayo Clinic reported complete responses in two patients with angiosarcoma, treated with TRC105 and Votrient, at the American Society of Clinical Oncology annual meeting in Chicago.

The company plans to treat additional patients with gestational trophoblastic neoplasia, or GTN, in a phase II multicenter trial that is expected to be initiated in the fourth quarter of 2015.

TRACON intends to apply for orphan drug status for TRC105 in GTN, as well as soft tissue sarcoma, by the end of the year.

TCON closed Friday's trading at $15.96, up 36.06%.