Agile Therapeutics Inches Closer to PDUFA for Twirla, Looks Bullish
Agile Therapeutics Inc. (AGRX) is, currently, waiting for the FDA decision for its lead drug candidate Twirla. The PDUFA date for the drug is set for February 16th. Despite several roadblocks faced by the proposed treatment so far, the prognosis is positive for Twirla. Further, the company is looking at a vast and highly lucrative market once the drug is given the nod by the FDA.
The US hormonal contraceptive market was estimated to be worth $7 billion in 2018. The market is mainly dominated by contraceptive pills. However, alternatives such as contraceptive patches are now gaining more acceptance.
Currently, Mylan Pharmaceuticals’ (NASDAQ:MYL) Xulane is the only government-approved female-centric contraceptive patch available in the market. It is the generic version of Ortho Evra and generated $211 million in revenue in 2016. Agile claims its product to be superior to Xulane on various counts. Twirla is a once-weekly patch and offers better adherence to the skin, making it safer and more convenient to use. According to the company, Twirla is looking at a nearly $4bn addressable market.
Twirla uses in-house developed Skinfusion technology, making Twirla the first contraceptive patch which is able to deliver LNG (levonorgestrel) through the skin. The comparative wear study conducted by Agile showed the non-inferior adhesiveness of Twirla in comparison to Xulane. The results indicated the mean adhesion score difference between Twirla and Xulane was -0.25 with the upper bound of the 95% confidence limit for the mean difference of -0.16. Overall, Twirla has the potential to become a favored method of contraception as it may provide freedom from the need to take daily pills.
Based on the data, it is safe to assume that Twirla is in a position to provide strong competition to Xulane upon its launch in the market after the approval. While frequent debacles had a negative impact on the stock market performance of Agile, it still managed to post over 200 percent gain in the past 12 months. With a very significant milestone just around the corner, the stock is expected to maintain its momentum. Agile stock presents an exciting opportunity for investors with high-risk appetite as a positive decision from the FDA will likely push the stock price even higher.
Twirla has a long and turbulent history behind it. The drug was initially subjected to the FDA scrutiny in 2012 when Agile filed an NDA submission to the regulator. The company received a Complete Response Letter from the FDA in 2013. Agile made another attempt to gain FDA approval in 2017 when it received yet another CRL, wherein the FDA raised questions about the adherence capacity of the patch and the manufacturing process undertaken.
The latest submission by Agile was made in the second quarter of 2019. The company provided additional information raised by the previous CRL to support the application. Consequently, the patch was scheduled to be evaluated by the FDA by November 16th, 2019. Later on, the FDA released a number of documents that were apparently critical of the product yet again.
However, this negative news was more than adequately countered by a positive vote of confidence given by the Bone, Reproductive, and Urologic Drugs Advisory Committee. The committee voted in favor of the patch 14 to 1, with one absence, stating that the benefits of the patch in preventing pregnancies prevail over the associated risks. The company proceeded to provide additional information after the board meeting.
Following the meeting, the FDA decided to extend the PDUFA for Twirla, stating that it requires more time to review the documents and data. The agency contended that the latest submission amounted to the major amendment. FDA, generally, resorts to PDUFA extension only in cases where the review of new information may lead to addressing an outstanding issue towards an approval. Also, though the agency is not bound by the opinion of the committee, it, generally, follows the committee’s lead.
The company chairman and chief executive officer Al Altomari said:
Between the resubmission and acceptance of our Twirla NDA as well as the announcement of the advisory committee meeting, we believe we are on track to seek the approval of Twirla.”
Agile seems optimistic about the FDA decision as the company is already planning the market debut of the patch. It plans to introduce the patch in the market by the fourth quarter of 2020. The company is also collaborating with patient payers and managed care providers for boosting the scope of Twirla.
The company recently reported that it is focusing on recruiting a team of marketing experts for the launch. Agile plans to hire and train an initial sales team during the second quarter of 2020. The team is estimated to comprise 50 to 90 marketing professionals. Additionally, the company will also focus on pitching the product to OBGYN and offer a large number of samples to boost the demand.
Abbott Laboratories is Granted Breakthrough Device Designation for Heart Pump
Abbott Laboratories (ABT) reported that the FDA has granted the Breakthrough Device designation to its implantable heart pump system. The pump is, currently, under development and is designed to be used for patients suffering from advanced heart problems requiring a heart transplant.
Abbott’s proposed system is an improvement over the current generation of left ventricular assist devices which are put directly into the body and work using either a charging port or an external battery. In contrast, FILVAS does not need any external component for its operations, leading to more convenience for the patients.
FILVAS is based on the HeartMate 3 Left Ventricular Assist Device technology which was acquired by the company through its acquisition of St. Jude Medical. The device has a lucrative market ahead as more than 600,000 patients require such intervention every year. FILVAS offers a substantial period of time where the patients may remain untethered.
Michael Pederson, senior vice president for Abbott’s electrophysiology and heart failure division said:
The potential for a fully implantable system would mean more freedom and a greater quality of life because there are no external components to be carried everywhere.
FILVAS will help Abbott in boosting its position in the cardiovascular segment as the company has built an arsenal of devices and therapies. Abbott recently announced the receipt of the CE mark for its Tendyne Transcatheter Mitral Valve Implantation system. It also received FDA approval for conducting a new trial for assessing the Amplatzer Amulet Left Atrial Appendage (LAA) Occluder for people with atrial fibrillation.
Abbott has already received the FDA nod for its HeartMate 3 device to be implanted using a novel procedure called a lateral thoracotomy. This new procedure is less invasive and may alleviate the need for open-heart surgery.
Thanks for reading. At the Total Pharma Tracker, we do more than follow biotech news. Using our IOMachine, our team of analysts work to be ahead of the curve.
That means that when the catalyst comes that will make or break a stock, we’ve positioned ourselves for success. And we share that positioning and all the analysis behind it with our members.
Disclosure: I am/we are long AGRX. 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.