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Pfizer’s Braftovi Approval, And Other News: The Good, Bad And Ugly Of Biopharma (NYSE:PFE)

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Via SeekingAlpha.com

Pfizer Gets FDA Approval for Braftovi in Colon Cancer Treatment

Pfizer (PFE) announced receiving the FDA nod for its Braftovi-Erbitux duo in some patients with metastatic BRAF-mutated colon cancer who have already been treated with chemotherapy. The approval also provided the company’s $11.4 billion acquisition of Array BioPharma last year, which brought BRAF inhibitor Braftovi and Mektovi to its portfolio. The merger was announced in June, 2019 and had valued Array stock at $48 apiece in cash.

Pfizer used the findings from a trial named Beacon for supporting its application. The trial involved the use of Braftovi and Erbitux and demonstrated that the combo improved overall survival to 8.4 months from 5.4 months for patients on chemo alone. The response rate for patients receiving the duo was 20%, in comparison to the response rate of 2% for those who were treated with chemo. The median progression-free survival was 4.2 months for patients on Braftovi and cetuximab combo compared to 1.5 months for patients in the control arm. Braftovi is now the first and only FDA-approved targeted regiment for the condition.

Braftovi is also under review for the similar indication in Europe. The application in the region was filed by Pierre Fabre, European partner of Array BioPharma. The latest FDA approval is the second one for Braftovi, which was earlier approved for treating metastatic melanoma with BRAF mutations. The approval was for the drug to be used in conjunction with Mektovi. Braftovi registered $48 million in revenue in 2019. The label expansion is likely to result in substantial increase in its revenue potential.

Braftovi is an oral small molecule kinase inhibitor targeting BRAFV600E, and Pfizer holds exclusive rights to the drug in the U.S. and Canada. Chris Boshoff, chief development officer, Oncology, Pfizer Global Product Development, said, “We are grateful to the patients and study investigators who participated in the Phase III BEACON CRC trial and are proud to now be able to offer a targeted treatment option for people with BRAFV600E-mutant metastatic CRC who have received prior therapy.” Pfizer is working towards boosting its targeted cancer drugs portfolio.

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Pfizer also reported developments on the COVID-19 front. The company stated that it has identified a drug candidate for fighting the pandemic and that it is aiming for testing the drug in the coming months. Pfizer claims that its drug candidate has shown the potential to block the COVID-19-causing virus from replicating itself. This feature may make the potential treatment to be helpful in aiding patients suffering mild to moderate form of infection.

Pfizer has partnered with BioNTech (BNTX), a German mRNA biotech firm, for developing the treatment. The firms will be carrying out joint clinical trials in the United States and in Europe at multiple sites. The companies will also work together to boost the supply of the drug and will be jointly responsible for global commercialization. Under this pact, BioNTech is entitled to receive $185 million in upfront payments, while there is also potential for additional $563 million disbursements.

Medtronic Receives Emergency Authorization to Sell Ventilators

Medtronic Plc (MDT) reported that it has received FDA approval for the use of its compact ventilators in the United States. The Puritan Bennett 560, or PB560, is expected to be available in the US markets soon. The authorization has been granted under the FDA’s Emergency Use Authorization pathway. The company is also collaborating with other technology partners and governments to design better products.

This FDA nod will allow the company to offer another ventilator option to medical professionals in the United States for treating patients suffering from COVID-19. PB560 is currently sold in 35 countries around the world and comes with a price tag of close to $10,000. The US demand for ventilators has increased multifold due to the coronavirus pandemic. The company stated that it is planning to increase its production capacity to meet the demand. Medtronic is looking to increase its production by almost five times to touch more than 1,000 ventilators per week by the end of the June. It is looking to supply over 25,000 machines over the course of the next six months.

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Medtronic is currently collaborating with two US hospitals for testing a new feature of its PB980 ventilator. The new feature lets medical professionals adjust the setting on the machine remotely. This feature is helpful in reducing the exposure of physicians to coronavirus. The company has a robust ventilator portfolio with other models such as PB840 and HT70. It is currently shipping more than 300 ventilators every week across the globe. The company is prioritizing production of the PB560 and PB980 models.

Medtronic recently launched an Open Source Initiative wherein it publicly shares the design specifications of the PB560 and participants from around the world can contribute. The initiative has already received more than 90,000 registrations for the design specifications.

Merck Suffers Setback over Bronchospasm Generic Approval

Merck (MRK) received a blow, as the FDA granted approval for a generic version of its Proventil HFA (albuterol sulfate) Metered Dose Inhaler, 90 mcg/Inhalation. The approval will allow India-based Cipla Limited to market its generic version of the treatment. The inhaler is designed to treat or prevent bronchospasm in patients four years or older suffering from reversible obstructive airway disease. It may also be used for the prevention of exercise-induced bronchospasm.

This is the first FDA approval for the generic version of the inhaler in the United States. FDA Commissioner Stephen M. Hahn, MD, said, “The FDA recognizes the increased demand for albuterol products during the novel coronavirus pandemic. We remain deeply committed to facilitating access to medical products to help address critical needs of the American public.” The FDA recently revised its product-specific guidance in March for proposed generic albuterol sulfate metered-dose inhalers, including drug products referencing Proventil HFA.

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Proventil HFA inhalation aerosol and its authorized generic equivalent had US sales of nearly $153 million for the 12-month period ending February 2020. Cipla MD and Global CEO Umang Vohra said, “We are pleased to receive the final approval for generic Albuterol MDI from the USFDA. This further strengthens our presence in the US market.” The company plans to start shipment of the product in a staggered manner.

Merck also announced its commitment to take cognizance of critical maternal health needs during the pandemic through its $3 million pledge. Merck for Mothers will direct investments to efforts in the U.S. and globally in countries impacted by COVID-19. The main aim of the pledge is to ensure maternal health during the current pandemic. The initiative will accept the proposals on an invitation-only basis. Merck has so far contributed or committed more than $11 million to COVID-19 relief efforts.

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Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.




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