Puma Inks License Deal To Commercialize Cancer Drug Nerlynx

Puma Biotechnology, Inc. (NASDAQ:PBYI) announced that it has inked an exclusive licensing agreement with Specialised Therapeutics Asia, a Singapore based biopharmaceutical company, to commercialize its breast cancer drug Nerlynx (neratinib) in Australia, New Zealand and South East Asia.

We remind investors that Nerlynx received an FDA approval in July for the extended adjuvant treatment of patients with early-stage HER2 over expressed/amplified breast cancer, who have been previously treated with Roche's (OTC:RHHBY) Herceptin-based adjuvant therapy. Notably, Nerlynx is the first anti-HER2 treatment to be approved by an extended adjuvant therapy for the aforementioned indication.

Notably, the drug is not approved in any other country except the United States. It is under review in the EU for the same indication.

Puma’s shares have significantly outperformed the industry so far this year. The stock has soared 233.6% compared with the industry’s 1.6% growth.

Pursuant to the agreement, Puma will be entitled to receive upfront and milestone payments of up to $4.5 million throughout the agreement tenure. Moreover, the company will receive double-digit royalties on Nerlynx sales in the regions where Specialised Therapeutics is responsible for commercializing the drug. Specialised Therapeutics will also seek to get the drug approved in additional countries including Singapore, Malaysia, Brunei and New Zealand.

Importantly, the company expects a regulatory approval for Nerlynx in Australia by the second quarter of 2019. Also, Specialised Therapeutics will speed up the process to make this therapy accessible in Australia through a Special Access Program, expected to start in the first quarter of 2018.

Several additional studies on Nerlynx targeting different types of breast cancer patient populations are currently underway. Puma believes that Nerlynx can also be developed for treating other kinds of cancer including non-small cell lung cancer (NSCLC) and tumor types that overexpress or have a mutation in HER2.

About 25% of HER2-positive early-stage breast cancer patients treated with Herceptin-based adjuvant treatment experiences a recurrence. Hence, the consent for Nerlynx in additional countries will be a huge boost to Puma as the company is expected to address the hugely unmet medical need of patients experiencing the relapse of the disease worldwide.

Zacks Rank & Key Picks

Puma carries a Zacks Rank #3 (Hold). Two better-ranked stocks in the health care sector are Ligand Pharmaceuticals Inc. (NASDAQ:LGND) and Achillion Pharmaceuticals, Inc. (NASDAQ:ACHN) , both carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Ligand’s earnings per share estimates have moved up from $3.68 to $3.70 for 2018 over the last 30 days. The company delivered positive earnings surprises in two of the trailing four quarters with an average beat of 8.22%. Share price of the company has surged 30.9% year to date.

Achillion’s loss per share estimates have narrowed from 65 cents to 63 cents for 2017 and from 74 cents to 67 cents for 2018 over the last 30 days. The company came up with positive earnings surprises in two of the trailing four quarters with an average beat of 4.51%.

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