Your Daily Pharma Scoop: Puma Progresses, Kala In Phase 3, Teva Fails

Summary

• Puma’s NDS is under review.
• Kala commences Phase 3 trial.
• Teva fails to reach Phase 2 endpoint.
• This idea was first discussed with members of my private investing community, The Total Pharma Tracker. To get an exclusive 'first look' at my best ideas, start your free trial today >>

Stocks in the News: PBYI, KALA

Puma Bio's Nerlynx marketing application in Canada under review

Puma Biotechnology's (NASDAQ:PBYI) New Drug Submission (‘NDS) for NERLYNX (neratinib) for the extended adjuvant treatment of adult patients with early-stage HER2-positive breast cancer is accepted for review by Health Canada. The current adjuvant therapy follows the earlier adjuvant trastuzumab-based therapy regime. As mandated by Health Canada, the candidate has now completed its mandatory validation period before moving to the review period.

The company claims that their therapy will be able to reduce the recurrence of the disease in patients with early stage HER2-positive breast cancer, following trastuzumab therapy. Last year in July FDA approved Neratinib and it is marketed as NERLYNX®. The drug is an oral irreversible pan-HER kinase inhibitor, was approved by the FDA in July 2017 for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy.

While the company waits the successful transition from positive CHMP June 2018 recommendation to marketing authorization from the European Commission, this approval comes as boost for the company. Three drug candidates — PB272 (neratinib, oral), PB272 (neratinib, intravenous) and PB357 — are in-licensed by the Puma for the global development and commercialization rights.

Over-expression of the HER2 protein occurs in ~20%-25% of breast cancer tumors. Further, this particular cancer sub-type is often more aggressive than other types of breast cancer. It is estimated that ~12.4% of American women will develop invasive breast cancer over the course of their lifetime. It is further estimated that in spite of decreasing rates there is apprehension of 40,920 women dying of breast cancer in the U.S. alone. The aggressiveness of the HER2 sub-type increases the risk of disease progression and may even lead to death. Trastuzumab can reduce the risk of early stage HER2-positive breast cancer returning after surgery. But in ~25% of patients treated with trastuzumab do experience recurrence.

Kala Pharma's third late-stage study of KPI-121 in dry eye disease underway

Phase 3 clinical trial of Kala Pharmaceuticals' (KAL) KPI-121 0.25% for the short-term treatment of dry eye disease recetly had its first patient dosed. The 900-subject study is should have its topline data available in Q4 2019.

In other News:

Teva's laquinimod flunks mid-stage study in Huntington's disease

Teva Pharmaceutical Industries (TEVA) Copaxone successor laquinimod failed in a Phase 2 clinical trial on the AhR activator as a treatment for Huntington's disease (‘HD). The primary endpoint could not sufficiently separate itself from the placebo baseline. However, the 1.0 mg dose cohort could meet the secondary endpoint as the percentage change in caudate volume from baseline to month 12.

FDA OKs Shionogi's lusutrombopag for low blood platelets in certain patients; ADRs up 7%

Shionogi's (OTCPK:SGIOF) Mulpleta (lusutrombopag) for the treatment of thrombocytopenia received FDA approval. This decision was conveyed much earlier than its PDUFA date of August 26. Thrombocytopenia is a condition when one suffers from a chronically low blood platelets.

Integer nabs FDA nod and CE Mark for RadialSeal vascular introducer

Integer Holdings' (ITGR) RadialSeal Introducer Kit, a radial guidewire used in interventional cardiology and peripheral vascular procedures receives FDA approval. The device is already CR marked.

Theratechnologies' Trogarzo application gets accelerated review in Europe; shares up 2%

Theratechnologies' (THERF) recently received accelerated review status for its marketing application for Trogarzo (ibalizumab-uiyk). The drug is indicated for treatment of HIV-1-positive adults who have not responded to other treatments. Due to this status, the normal review period of 210 days will now be reduced to 150 days.

U.S. healthcare spending nearing 20% of GDP

According to a recent WSJ report the U.S. healthcare spending will soon reach 20% of GDP. The figure is significantly higher than any other members of the 7 MM. The bulging bill is not caused by higher demand, but by increased cost. In the last 60 years the medicals costs have risen 2000% compared to the CPI rise of ~700%. In spite of such higher proportion of health related spending, the country lags behind in many health indicators like life expectancy, diabetes incidence, respiratory and cardiac health and infant mortality.

Immutep on go to start mid-stage study of eftilagimod alpha

Immutep Limited's (IMMP) IND for IMP321 (eftilagimod alpha), a LAG-3Ig fusion protein receives FDA sign-off for its Phase 2 clinical trial evaluating the combination of IMP321 and Merck's KEYTRUDA (pembrolizumab) in patients with non-small cell lung cancer (‘NSCLC) or head and neck carcinoma later this year. Estimated date for preliminary results is 2019.

Eiger BioPharma receives notice of allowance from U.S. Patent Office covering lonafarnib in HDV

USPTO recently issued notice of allowance to Eiger BioPharmaceuticals (EIGR) for its application number 15/335,327 entitled "Treatment of Hepatitis Delta Virus Infection,". The patent application will cover a broad range of (‘RTV)-boosted lonafarnib doses and durations.

Oxford Immunotec launches T-Cell Select in Europe and ROW countries

Oxford Immunotec (NASDAQ:OXFD) launched T-Cell Select kit in Europe and select ROW countries. The new kit is now CE-marked. The T-Cell kit will now allow customers to have a fully automated solution for the T-SPOT.TB test.

Novelion's Myalepta OK'd in Europe; shares up 16% premarket

Novelion Therapeutics' (NVLN) MYALEPTA (metreleptin) is approved by the European Commission as an adjunct to diet as replacement therapy to treat complications of leptin deficiency (‘LD) in various patient groups with diferent sources of complications.

Antibe's timeline for mid-stage study of ATB-346 extended, metabolism protocol added

Antibe Therapeutics (OTCQX:ATBPF) announced that Phase 2 clinical trial of its lead candidate ATB-346 will now include a metabolism protocol. Earlier the trial included only a dose-ranging efficacy portion. The trial should start shortly and will be conducted over a 8-10 week period. Topline efficay data should be available in 2Q 2019.

Lenvima/Keytruda combo a Breakthrough Therapy for type of endometrial cancer

FDA designated the combination of KEYTRUDA (pembrolizumab) and LENVIMA (lenvatinib) a Breakthrough Therapy. The combination is on trial for the potential treatment of patients with advanced and/or metastatic non-microsatellite instability high/proficient mismatch pair endometrial carcinoma. The combination is currently i n Phase 1b/2 stage of development.

Expanded use of Bristol-Myers' Opdivo OK'd in Europe

Bristol-Myers Squibb's (NYSE:BMY) Opdivo (nivolumab) receives European commission’s approval for treatment of adult patients with melanoma involving lymph nodes or metastatic cancer who have undergone complete resection. This is the eighth approval received by Opdivo for six different types of tumors.

Pfizer's Herceptin biosimilar OK'd in Europe

Pfizer's (NYSE:PFE) TRAZIMERA receives European Commission’s approval following an earlier CHMP opinion last May. TRAZIMERA is a biosimilar of Roche's (OTCQX:RHHBY) cancer med Herceptin (trastuzumab).

FDA OKs Medtronic's implantable system for Remodulin

The FDA approves Medtronic's (NYSE:MDT) Implantable System for Remodulin (treprostinil) received FDA approval for treatment of patients with pulmonary arterial hypertension (‘PAH).

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