VNDA Soars, CEMI Secures Zika Contract, EMA To Review MYL's Proposed Biosimilar

(RTTNews) - Chembio Diagnostics Inc. (CEMI) has been awarded up to $13.2 million U.S. Government contract for the development and commercialization of the company's rapid POC Zika test and Zika-related products.

An initial commitment of $5.9 million is allocated specifically to the company's DPP Zika IgM/IgG Assay and DPP Micro Reader, and an additional $7.3 million is for the development, clinical trial and regulatory submissions related to the company's DPP Zika/Chikungunya/Dengue IgM/IgG Combination Assay.

CEMI closed Thursday's trading 14.94% higher at $7.00.

Mylan N.V.'s (MYL) Marketing Authorization Application for a proposed biosimilar Trastuzumab, which is used to treat certain HER2-positive breast and gastric cancers, has been accepted for review by the European Medicines Agency.

Mylan is developing the proposed biosimilar in partnership with India's Biocon Ltd. This is the second biosimilar submission developed by the partnership that has been accepted for review in Europe. Last month, Mylan's MAA for the proposed biosimilar Pegfilgrastim was accepted for review by EMA.

MYL closed Thursday's trading at $42.85, down 0.70%.

Shares of Vanda Pharmaceuticals Inc. (VNDA) soared more than 20% on Thursday, following a favorable verdict in the patent litigation against Roxane Laboratories Inc. related to schizophrenia drug Fanapt.

Fanapt, which garnered sales of $65.6 million in 2015, is Vanda's top-selling drug.

Roxane has been seeking to market a generic version of Fanapt even before the patent expiry of the drug, which led to Vanda filing a patent suit against Roxane in 2014. In its patent suit, Vanda asserted that Roxane is infringing on '610 patent, which expires November 2027, and the RE'198 patent, which expires November 2016.

A counter suit was filed by Roxane seeking invalidity and non-infringement of Vanda's patents.

The case has gone in Vanda's favor - with the judge ruling that "Roxane infringed the two patents by submitting to the FDA an ANDA seeking permission to market a generic version of Fanapt before the expiration of Vanda's patents".

VNDA closed Thursday's trading at $14.17, up 20.60%.