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By PharmaCompass
2022-07-07
Impressions: 1510
New Jersey-based Merck is reportedly in advance talks to buy cancer-focused biotech Seagen in a deal estimated at around US$ 40 billion or more. The two companies are likely to seal the deal before July 28.
In Phispers this week, we also bring you news that British pharma major GSK’s consumer healthcare spin-off – Haleon – will have a debt of around £10.3 billion (US$ 12.5 billion) when it lists as a separate company on the London Stock Exchange on July 18. And given the prevailing tough market conditions for a potential private equity sale, Novartis is leaning towards a spin-off of its generic drug unit Sandoz.
After its manufacturing facility in Baddi, Himachal Pradesh (India), received a Form 483 with six observations last month, Indian drugmaker Glenmark Pharmaceuticals’ formulation manufacturing facility in Aurangabad has received another Form 483 with one observation from the US Food and Drug Administration (FDA). Another Indian drugmaker Cipla’s Indore plant has also been hit by a Form 483 with two observations.
AstraZeneca’s cancer drug Imfinzi, in combination with chemotherapy, has shown positive results in a late-stage trial in patients with non-small cell lung cancer (NSCLC). The drug plus chemo combo, when given before surgery, has proven to be more effective in removing cancer cells than just chemotherapy. The Anglo-Swedish drugmaker is also acquiring US biotech TeneoTwo for around US$ 1.27 billion to boost its portfolio of blood cancer therapies.
In regulatory news, the FDA has granted a priority review to Roche’s immunotherapy — Lunsumio — to treat adult patients with relapsed or refractory follicular lymphoma who have received at least two prior systemic therapies. The agency is expected to take a decision on the drug by December 29. In a setback for Sanofi, the FDA has put a partial hold on phase 3 studies of the French pharma’s oral drug tolebrutinib in multiple sclerosis (MS) and myasthenia gravis, following reports of drug-induced liver injury in patients.
The FDA has lifted a clinical hold on a phase 1/2 clinical trial of Vertex Pharmaceuticals’ diabetes drug candidate — VX-880. The agency had placed the hold in May due to insufficient information to support dose escalation with the product. The agency has also lifted a clinical hold on Dyne Therapeutics’ Duchenne muscular dystrophy (DMD) drug candidate DYNE-251. The agency had placed a hold on the drug candidate in January.
Amylyx Pharmaceuticals’ ALS drug candidate – AMX0035 – will get a second chance to persuade FDA advisers that its experimental ALS drug is effective, as the FDA has decided to reconvene a meeting to discuss Amylyx’s application for the experimental drug. The meeting will take place on September 7. The FDA has also granted a priority review to Eisai and Biogen’s experimental Alzheimer’s drug – lecanemab. The agency has set January 6, 2023, as the PDUFA date.
Merck in advanced talks to buy cancer drugmaker Seagen for around US$ 40 billion
Last month, we had carried news on Merck’s plans to buy Washington-based biotech Seagen to boost its cancer drugs portfolio. The talks have now reached an advanced stage, according to a report published in The Wall Street Journal. The deal is estimated to be worth US$ 40 billion or more. The two pharmas are discussing a price above US$ 200 a share for Seagen, the report said.
New Jersey-based Merck and Seagen are planning to seal the deal before the announcement of Merck’s second-quarter earnings, set for July 28, the WSJ report said. There is still no guarantee that the companies will reach an agreement on a takeover deal. Any proposed deal will also draw a close inspection from antitrust officials.
If the deal goes through, Merck will successfully broaden its line-up of oncology drugs, which is currently led by Keytruda, an immunotherapy that brought in US$ 17.2 billion in sales last year.
GSK’s Haleon to have US$ 12.5 billion in debt when it spins off later this month
British pharma major GSK’s consumer healthcare spin-off – Haleon – will have a debt of around £10.3 billion (US$ 12.5 billion) when it lists as a separate company on the London stock market on July 18. This is around four times its estimated earnings for this year, according to analysts at investment bank Barclays. Analysts at broker Jefferies also said the amount of debt was 'notably high’ by stock market standards, but said the company will benefit from its position as a ‘largely unique asset’ on the London and global stock markets.
Haleon is expected to reach a valuation of around £38-45 billion (US$ 46-54.5 billion) when it lists. This is less than the £50 billion (US$ 68.4 billion) that Unilever had offered for the unit. GSK had rejected the bid a few months ago saying Unilever’s offer had “fundamentally undervalued” the business and its future prospects.
Glenmark’s second Indian facility, Cipla’s Indore plant hit by FDA’s Form 483s
Indian drugmaker Glenmark Pharmaceuticals seems to have hit a spell of bad luck with the FDA. Last month, its manufacturing facility in Baddi, Himachal Pradesh (India), received a Form 483 with six observations. The agency had inspected the site between June 13 and 22.
And this month, the FDA issued another Form 483 with one observation to Glenmark’s formulation manufacturing facility in Aurangabad, India. The agency inspected the site between June 27 and July 1. Spread over 30 acres, the Aurangabad facility manufactures oral solid dosage, inhaler and foam formulations.
The company said it is taking all necessary steps to address the observations. In May this year, the drugmaker’s formulation manufacturing facility in Monroe, North Carolina (US), was issued a Form 483 with 17 observations by the FDA, following an inspection between April 4 and May 19. The pharma had done a voluntary recall of all its products from its Monroe site in August 2021 and has not been commercializing any product from this site since then. Its manufacturing facility in Goa, India, also received another Form 483 with five observations in May.
Cipla’s Indore plant gets Form 483 with two observations: The FDA has issued a Form 483 with two observations to Indian drugmaker Cipla’s Indore plant during a pre-approval inspection between June 27 and July 1. The Form 483 is regarding an Abbreviated New Drug Application filed for a product that the company is planning to manufacture at the plant. There is no data integrity observation, Cipla said. The company said it is committed to addressing these observations and will submit its response to the FDA within the stipulated time.
Novartis leans towards Sandoz spin-off, to take final decision by 2022-end
Given the challenging market conditions for a potential sale to private equity firms, Novartis is mulling a spin-off of its generic drug unit Sandoz, Bloomberg reported, citing sources.
Novartis had kicked off a strategic review of Sandoz in October last year, keeping all options on the table, including retaining the business and spinning it off. The strategic review is still on, and the Swiss pharma giant is continuing to explore all options. Novartis plans to offer an update on the review by the year-end.
Since October, Novartis has received several offers for the generic drug unit. Back in February, Bloomberg had reported that private equity firms Blackstone and Carlyle Group are considering a US$ 25 billion joint offer for Sandoz. In October, German newspaper Handelsblatt had reported that Sweden-based investment group EQT and the Struengmann family of Germany were considering a joint move to purchase Sandoz for US$ 21.6 billion.
Roche’s follicular lymphoma drug gets FDA priority review, eyes year-end verdict
Last month, Lunsumio became the first CD20xCD3 bispecific antibody approved anywhere in the world after it received a conditional authorization from the European Commission. And this week, the FDA granted a priority review to Roche’s immunotherapy Lunsumio (mosunetuzumab) to treat adult patients with relapsed or refractory follicular lymphoma who have received at least two prior systemic therapies. The agency is expected to take a decision on the CD20xCD3 bispecific for follicular lymphoma by December 29.
Roche’s application is based on data from a phase 1/2 study where Lunsumio shrank tumors in 80 percent of heavily pretreated follicular lymphoma patients and cleared signs of tumors in 60 percent of patients after a median follow-up of 18.3 months.
AstraZeneca’s Imfinzi plus chemo combo shows promise in phase 3 lung cancer trial
AstraZeneca said its cancer drug Imfinzi, in combination with chemotherapy, has shown positive results in a late-stage trial in patients suffering from an aggressive form of lung cancer. The Anglo-Swedish drugmaker said the combination, when given before surgery, is more effective in removing cancer cells as compared to just chemotherapy in patients with non-small cell lung cancer (NSCLC). The pharma said the phase 3 trial will continue to assess the study’s main goal of disease-free survival.
The pharma plans to share the interim data with health regulatory authorities globally. It also has several ongoing trials testing Imfinzi in the early stages of lung cancer. Imfinzi is approved in the US, Japan, China and many EU countries for stage 3 NSCLC in patients whose disease has not progressed after chemo-radiotherapy. The drug generated US$ 2.41 billion in 2021 sales.
To acquire TeneoTwo for potential US$ 1.27 billion: AstraZeneca will acquire US biotech TeneoTwo for around US$ 1.27 billion in a move to bolster its portfolio of blood cancer therapies. Astra will acquire all outstanding equity of TeneoTwo for an upfront payment of US$ 100 million. TeneoTwo may receive additional milestone-related payments of up to US$ 1.17 billion.
The deal will give AstraZeneca rights to TeneoTwo's experimental drug TNB-486, which is in a phase 1 trial in patients with B-cell non-Hodgkin’s lymphoma, a type of cancer that involves the growth of abnormal white blood cells that can lead to the emergence of tumors. The transaction is likely to close in the third quarter of this year.
FDA puts late-stage trials of Sanofi’s MS drug on hold after reports of liver injury
The FDA has put a partial hold on phase 3 studies of Sanofi’s oral drug tolebrutinib in multiple sclerosis (MS) and myasthenia gravis following reports of drug-induced liver injury in patients. Sanofi had acquired the drug through the acquisition of Principia Biopharma in 2020.
The French drugmaker has paused new enrollment in the US following the hold. The agency imposed the restrictions following “a limited number of cases of drug-induced liver injury,” Sanofi said. The elevations indicating liver injury in these patients were reversed once the drug was discontinued.
Lifts clinical hold on Vertex’s diabetes cell therapy: The FDA has lifted a clinical hold on a phase 1/2 clinical trial of Vertex Pharmaceuticals’ diabetes drug candidate VX-880. The agency had placed the clinical hold on the type 1 diabetes drug in May due to insufficient information to support dose escalation.
Vertex said the planned 17-person trial for VX-880 is back on track after the agency lifted the hold. The pharma did not say whether the agency has requested any amendments to the dosing design.
VX-880 is an off-the-shelf stem cell therapy using islet cells, which produce hormones in the pancreas that help control glucose levels. It is designed to replace insulin-producing cells (that type 1 diabetes patients lose) with lab-grown insulin-producing cells.
The agency has also lifted a clinical hold on Dyne Therapeutics’ Duchenne muscular dystrophy (DMD) drug candidate DYNE-251. The agency had placed a hold on the drug candidate in January, requesting additional clinical and nonclinical information from Dyne.
Amylyx’s ALS drug candidate gets another chance to score US approval
Back in March, a panel of external advisers to the FDA had narrowly voted against Amylyx Pharmaceuticals’ ALS drug candidate – AMX0035. The biotech will now get a second chance to persuade the FDA advisers that its experimental ALS drug is effective, as the FDA has decided to reconvene another meeting to discuss Amylyx’s application for the experimental drug.
The meeting will take place on September 7. Amyotrophic lateral sclerosis or ALS is a neurodegenerative disorder with few treatment options. If approved, AMX0035 will be the first new ALS drug to enter the US market in more than five years.
FDA to decide on Eisai-Biogen’s Alzheimer’s drug in Jan: The FDA has granted a priority review to Eisai and Biogen’s experimental Alzheimer’s drug – lecanemab. The agency has set January 6, 2023, as the PDUFA date. Like Biogen’s Aduhelm, lecanemab is an antibody designed to remove sticky deposits of a protein called amyloid beta from the brains of people with early Alzheimer’s disease.
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