Radius Health Down on Negative CHMP Opinion for Lead Drug

Shares of Radius Health RDUS fell 4% after the company suffered a setback once again in Europe.

Overall, Radius Health’s shares have lost 7% in the last six months as against the industry’s  gain of 3.2%.

 

 

The scientific committee of the European Commission, Committee for Medicinal Products for Human Use (“CHMP”), rendered a negative trend vote on the benefit-risk balance for the marketing authorization application (“MAA”) for abaloparatide-SC in an oral explanation. The CHMP will therefore adopt a negative opinion on the same. The company was planning to get abaloparatide-SC approved for the treatment of osteoporosis in postmenopausal women at increased risk for fracture.

Radius Health plans to seek a re-examination of the CHMP opinion.

In December 2017, the CHMP issued a third Day-180 List of Outstanding Issues and informed the company that it intends to refer the MAA to a scientific advisory group for additional advice. The company has earlier issued a second Day-180 List of Outstanding Issues. The delay in getting approval in Europe is disappointing given the market potential.

We note that abaloparatide injection was approved by the FDA in April 2017 under the brand name Tymlos for the treatment of postmenopausal women with osteoporosis at high risk for fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy.

Tymlos continues to gain traction with approximately 259 million covered lives and 93% coverage in commercial plans. Tymlos market share reached approximately 32% of new patients starting anabolic therapy (NBRx) and 13% of total prescriptions in the anabolic market.

Although the osteoporosis market in the United Sates has great potential as approximately 1.4 million postmenopausal women experience an osteoporotic fractur each year, Tymlos is expected to face significant competition from Eli Lilly & Co's LLY Forteo and Amgen's AMGN Prolia.

Radius Health’s pipeline includes an abaloparatide patch for potential use in osteoporosis; elacestrant (RAD1901) for the treatment of hormone-receptor positive breast cancer and RAD140, a non-steroidal, selective androgen receptor modulator which is being evaluated for use in hormone-receptor positive breast cancer.

Zacks Rank & Key Pick

Radius Health currently carries a Zacks Rank #3 (Hold).

A better-ranked stock in the health care sector is Regeneron Pharmaceuticals REGN which sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Regeneron’s earnings per share estimates have moved up to $18.68 from $18.65 in the last 30 days. The company pulled off a positive earnings surprise in three of the last four quarters with an average beat of 9.15%.

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