TORONTO - BioCryst (NASDAQ:BCRX) Pharmaceuticals, Inc. (NASDAQ:BCRX) has reached a key milestone in expanding access to its hereditary angioedema (HAE) treatment, PrORLADEYO® (berotralstat), in Canada. The pharmaceutical company announced today that it successfully concluded negotiations with the pan-Canadian Pharmaceutical Alliance (pCPA) to incorporate the drug into public formularies, paving the way for broader patient access through the country's publicly funded healthcare system.
PrORLADEYO®, an oral, once-daily medication approved by Health Canada in June 2022 for the routine prevention of HAE attacks in adults and pediatric patients aged 12 and older, represents a significant advancement in the management of this rare condition. The completion of negotiations with pCPA signifies a crucial step in BioCryst's mission to provide this prophylactic therapy to as many HAE patients as possible.
Michelle Cooper, president of HAE Canada, expressed appreciation for the collaboration between BioCryst and pCPA, underscoring the importance of making ORLADEYO accessible to improve the quality of life for those living with HAE. Anand Janack, vice president and general manager of BioCryst Canada, echoed this sentiment, highlighting the swift progress made since Health Canada's approval, including positive recommendations from Canada's Drug Agency and INESSS in March and September 2023, respectively.
While some Canadian patients with HAE have been able to obtain ORLADEYO through private health insurance, the new agreement will facilitate access for those relying on public health coverage. BioCryst will now work with individual provincial and territorial drug plans to ensure the inclusion of ORLADEYO in their respective formularies.
PrORLADEYO® works by reducing the activity of plasma kallikrein to prevent HAE attacks. Its safety profile has been evaluated in multiple long-term clinical studies, with the most common adverse reactions being gastrointestinal in nature. The drug is not recommended for acute HAE attacks or for patients with moderate or severe hepatic impairment due to increased serum berotralstat concentrations.
This announcement is based on a press release statement from BioCryst Pharmaceuticals , Inc. and marks an important development for HAE patients in Canada seeking new treatment options.
In other recent news, BioCryst Pharmaceuticals Inc. has seen robust performance in the second quarter of 2024, primarily driven by the demand for its hereditary angioedema treatment, ORLADEYO. The company has raised its revenue forecast for the year to a range of $420 million to $435 million. BioCryst has also appointed Dr. Donald S. Fong as the company's new chief medical officer, bolstering their medical team. However, the company announced the discontinuation of its BCX10013 program due to the drug's inadequate activity.
BioCryst is planning to file for pediatric use of ORLADEYO's oral-granule formulation next year, as part of its promising pipeline developments. The company is also expecting to reach 85% paid treatment in the US by 2029 and is targeting a 20% market share for ORLADEYO. With strong sales and patient retention of ORLADEYO in over 20 countries, the firm has expressed optimism about achieving profitability and maintaining independence from capital markets. These developments indicate a positive trajectory for BioCryst despite the discontinuation of BCX10013.
InvestingPro Insights
In the wake of BioCryst Pharmaceuticals' significant progress in Canada with its HAE treatment, PrORLADEYO®, investors and industry observers are closely monitoring the company's financial health and market performance. According to InvestingPro, BioCryst has experienced a strong return over the last three months, with a 26.92% increase in its total price return, indicating robust investor confidence in the wake of recent developments.
The company's market capitalization stands at approximately 1.64 billion USD, reflecting its current valuation in the market. Despite not being profitable over the last twelve months, BioCryst has demonstrated a solid revenue growth of 24.65% during the same period. This suggests that while the company is investing heavily in its products and market expansion, there is a clear upward trajectory in sales that could eventually lead to profitability.
An InvestingPro Tip to consider is that analysts have revised their earnings upwards for the upcoming period, which could be a signal of anticipated growth or positive developments within the company. Moreover, it's worth noting that BioCryst's liquid assets exceed its short-term obligations, providing the company with a solid financial footing to manage its operations and continue its expansion efforts.
For those interested in further analysis and metrics on BioCryst Pharmaceuticals, InvestingPro offers additional insights and tips. There are currently a total of 9 InvestingPro Tips available on their platform, which can provide a deeper understanding of the company's financials and market potential.
These insights are particularly relevant as BioCryst continues to navigate the pharmaceutical landscape and seeks to expand the reach of its HAE treatment. With a clear focus on improving patient access and a promising financial outlook, BioCryst is a company to watch in the biopharmaceutical sector.
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