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Last month, we had Eyes On some of the latest approvals, M&A activities, and litigation. Here are a few that caught our interest - AbbVie's Vyalev approval, Genentech's deal with Regor Pharma, Lundbeck's Longboard acquisition, and GSK's additional litigation around mRNA vaccine Intellectual Property. What caught your eye?
Nearly ten years ago, AbbVie scored with its Parkinson's disease infusion pump therapy Duopa, a delivery system innovation that sidestepped the drawbacks of oral medicines. After several delays, the company has now received FDA approval for its more convenient, subcutaneous follow-up, Vyalev, formerly known as ABBV-951. The prodrugs for the standard-of-care medications carbidopa and levodopa, foscarbidopa and foslevodopa, are included in the drug. Drug derivatives known as prodrugs become active once they enter the body. For people with advanced Parkinson's disease, the therapy is administered as a continuous infusion for 24 hours.
AbbVie already sells Duopa, a combination of carbidopa and levodopa. Duopa is delivered straight to the small intestine via a stomach tube, which must be implanted surgically. The company's next move after Duopa is Vyalev. With a pump that constantly administers the medication beneath the skin, the delivery method offers a significant convenience advantage over its predecessor while avoiding the drawbacks of oral medicines, such as their short half-life, which makes it challenging to manage symptoms over time. Over the course of the next year or two, analysts predict that Vyalev could be one of AbbVie's largest new pharmaceutical launches, with peak revenues of over $2 billion.
When compared to oral levodopa/carbidopa at Week 12, the medication dramatically increased the patient's "on" time without dyskinesia, indicating that the patient's involuntary movements were under control. This was shown in a phase 3 research. Over a period of several days, the average "on" time during a 16-hour wake period increased by 2.72 hours for patients receiving Vyalev treatment compared to 0.9 hours for the control group. For those who have had Parkinson's disease for a number of years, dyskinesia is a frequent side effect of long-term levodopa therapy.
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From PharmaTell
Genentech is purchasing Regor Pharmaceuticals' CDK inhibitor portfolio for $850 million upfront. the company is acquiring a breast cancer candidate that has demonstrated single-agent efficacy in patients who have not responded to current treatments.
Late last year, the Chinese-American biotech company Regor released phase 1a data for their next-generation CDK inhibitor. The biotech designed the therapeutic candidate to have selectivity against CDK6, high potency against CDK4, and enhanced activity against CDK2. These characteristics are meant to reduce haematologic toxicity and overcome resistance to CDK4/6 inhibition.
The chemical, known as RGT-419B, is being tested in patients with advanced or metastatic breast cancer who have hormone receptor (HR)-positive, HER2-negative that progressed while using previous CDK4/6 inhibitors. Ibrance, a CDK4/6 inhibitor made by Pfizer, was previously administered to all 12 women in the trial. Two patients had also taken other licensed CDK inhibitors, such as Verzenio from Eli Lilly or Kisqali from Novartis.
Regor saw two confirmed partial responses during dose escalation and one unconfirmed partial response. Regor plans dose increases of RGT-419B as a single drug and in combination with endocrine therapy due to the monotherapy's 28.6% verified partial response rate in seven patients with detectable illness and the lack of grade 3 or higher side effects.
Regor will oversee the conclusion of two ongoing RGT-419B phase 1 trials. Genentech will oversee clinical development, manufacturing, and global commercialization. As the CDK inhibitors progress, Genentech may pay undisclosed development, regulatory, and commercial milestones.
Genetech's push into HR-positive breast cancer, which accounts for about 70% of all cases, continues with the purchase of RGT-419B. The company is developing inavolisib, a P13K inhibitor, and giredestrant, a selective endocrine receptor degrader, for HR-positive diseases. The company views giredestrant as a possible substitute for endocrine treatments that work well with CDK inhibitors. A key component of their strategy to distinguish the P13K inhibitor is its ability to combine inavolisib with CDK inhibitors.
Genentech has previously coupled its CDK inhibitors with those from Lilly, Novartis, and Pfizer. However, Genentech will have its own CDK inhibitors with the acquisition of the Regor portfolio, which is expected to be confirmed in the fourth quarter.
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From PharmaTell
From PR Newswire
GSK is suing Moderna in two lawsuits, claiming the Massachusetts-based biotech violated several patents with its two licensed mRNA vaccines. This comes nearly six months after the company filed a similar case against Pfizer and BioNTech over the COVID injection, Comirnaty.
GSK filed a lawsuit against Moderna in Delaware federal court, claiming the mRNA expert disregarded GSK-owned patents regarding the technique used to create lipid mRNA vaccines. The lawsuits focus on Moderna's COVID-19 vaccine, Spikevax, and its more recently authorized mRNA vaccine for the respiratory syncytial virus (RSV), mRESVIA. According to GSK, Moderna is selling the products without licensing them, infringing on GSK's intellectual property.
According to GSK's legal team, Moderna didn't begin investigating lipid encapsulation and distribution for RNA vaccines until after the method's basic work was made public. GSK acquired the methodology in 2015 after acquiring a large portion of Novartis' vaccine business. GSK further argues that Moderna hired several former Novartis and GSK personnel with first-hand expertise, which allowed Moderna to acquire technical know-how related to the company's mRNA vaccine platform.
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From Reuters
Lundbeck, a brain disease-focused pharmaceutical company, is paying $2.5 billion to acquire Longboard Pharmaceuticals and its groundbreaking epilepsy medication.
The buyout revolves around bexicaserin, a 5-HT2C receptor agonist that caused the biotech's stock to soar early this year after an early-stage trial revealed it could cut the incidences of seizures in a group of challenging epilepsy illnesses in half.
Lundbeck has now committed to buying Longboard for $60 per share, significantly higher than the stock’s close of $38.90 at the end of that week. This will generate a cash price tag of $2.5 billion.
While the open-label extension of the phase 1b/2a trial in uncommon epilepsy syndromes such as Dravet and Lennox-Gastaut is still underway, Bexicaserin began a phase 3 trial in September for seizures linked to Dravet syndrome in patients two years of age and older.
With a target of $1.5 billion to $2 billion in global peak sales, Lundbeck plans to introduce bexicaserin in the last quarter of 2028. If all goes according to plan, the acquisition should diversify revenue growth and enhance Lundbeck's mid-to-late-stage pipeline.
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