Nuvo To Split Into Two, BSPM Regains Compliance, PFE Gets FDA Nod

(RTTNews) - Alexza Pharmaceuticals Inc. (ALXA) has reacquired the U.S. commercial rights for antipsychotic ADASUVE from Teva Pharmaceuticals USA Inc., a subsidiary of Teva Pharmaceutical Industries Ltd. (TEVA).

Alexza granted Teva license to market ADASUVE in the U.S. in May 2013.

Following the reacquisition, the two companies have also restructured the obligations under the outstanding note from Teva.

Accordingly, Alexza will issue approximately 2.17 million shares to Teva as consideration for the reduction in the Teva note by $5 million of principal and forgiveness of all accrued and unpaid interest. After the share issuance, Teva will own approximately 9.9% of Alexza's outstanding common stock.

The remaining Teva note balance will become payable in the first calendar year following the calendar year in which the aggregate annual net sales of ADASUVE and any other Staccato-based products first reach $50 million in the U.S. After the U.S. sales reach this threshold, the $20 million note balance will be due and will be payable in four consecutive annual payments of $5 million each, noted Alexza.

ALXA closed Wednesday's trading at $0.29, up 2.57%.

Biostar Pharmaceuticals Inc. (BSPM) announced that it was notified by NASDAQ on February 22, 2016 that it had regained compliance with the minimum bid price listing rule.

BSPM closed Wednesday's trading at $2.27, down 7.83%.

The Ontario Superior Court of Justice has green-lighted the reorganization of Nuvo Research Inc. (NRI.TO) into two separate publicly traded companies namely, Nuvo Pharmaceuticals Inc. and Crescita Therapeutics Inc.

Nuvo Pharmaceuticals would be a revenue and EBITDA generating commercial healthcare company to be owned 100% by Nuvo shareholders. Crescita would be a drug development company also initially owned 100% by Nuvo shareholders.

Accordingly, shareholders who purchase Nuvo Pharma common shares through the facilities of the TSX prior to the close of trading on March 4, 2016 will automatically receive one Crescita common share. Crescita common shares are expected to start trading on the TSX under ticker "CTX" on March 7, 2016.

NRI.TO closed Wednesday's trading at C$6.38, down 3.33%.

Pfizer Inc. (PFE) has received FDA approval for its Xeljanz XR, extended-release 11 mg tablets, intended for the once-daily treatment of moderate to severe rheumatoid arthritis (RA) in patients who have had an inadequate response or intolerance to methotrexate.

The FDA had approved Xeljanz in dosage strength of 5 mg twice daily for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate in 2012.

Xeljanz racked up $523 million in sales last year, and according to DrugAnalyst, an independent Pharmaceuticals Equity Research provider, the drug is expected to garner sales of $770 million in 2016.

PFE closed Wednesday's trading at $30.02, up 0.20%.

Relypsa Inc. (RLYP) plans to submit a supplemental New Drug Application by mid-2016 requesting a label change for its hyperkalemia therapy Veltassa.

The company is expected to submit a Marketing Authorization Application for Veltassa for the treatment of hyperkalemia to the European Medicines Agency in the first half of 2016.

Due to ongoing commercialization of Veltassa in the United States and initiation of additional clinical studies with Veltassa, the company expects 2016 total operating expenses to be in the range of approximately $275.0 to $300.0 million. The company's operating expenses in 2015 was $196.4 million.

RLYP closed Wednesday's trading at $16.78, down 2.39%. In after hours, the stock was down another 12.51% to $14.68.