Sanofi/REGN

Out of interest, I know a few eyes here are on dupilumab, alirocumab and obviously eylea:


Regeneron says allergy drug may be darling of its pipeline

By Ransdell Pierson
Fri Sep 19, 2014 3:29pm EDT

(Reuters) - Regeneron Pharmaceuticals Inc has quickly become one of the world's biggest biotech companies thanks to its Eylea treatment for macular degeneration, but its little known experimental allergy drug could become equally successful, senior company executives said in interviews.

The allergy drug, dupilumab, is meant to treat underlying causes of asthma, eczema and nasal polyps and could transform treatment of those suspected related ailments, the officials say.
"We have a lot of debate within the company as to which of our many programs is the most exciting, and a lot of people are voting on dupilumab," Regeneron research chief George Yancopoulos said in an interview at company headquarters.

The other contender is a new type of cholesterol treatment, called alirocumab, which Regeneron expects to submit for regulatory approval later this year.

Dupilumab works by blocking IL-4 and IL-13, two immune system proteins that attack healthy tissue and cause inflammation in different parts of the body. The medicine, co-developed with French drugmaker Sanofi, slashed asthma flareups by 87 percent in a mid-stage trial described last year.
A measurement of eczema symptoms and surface area involvement diminished by 45 to 74 percent in a separate mid-stage trial of dupilumab described in July. It involved patients with moderate to severe atopic dermatitis, a chronic type of eczema.

Data from mid-stage trials of the drug against nasal polyps - growths that impair smell, breathing and sleeping and which are linked to sinus infections - are expected in coming months and could give a fuller portrait of dupilumab's potential.

"If dupilumab is equally impressive against nasal polyps, I think it will nail the hypothesis that this spectrum of allergic diseases are all inter-related variations of the same disease" and due to the inflammation-causing proteins, Yancopoulos said.

Millions of people worldwide suffer from various combinations of asthma, nasal polyps and atopic dermatitis, pointing to potential high demand for dupilumab, Yancopoulos said.

Regeneron was an obscure biotech in the northern suburbs of New York City until late 2011, when it introduced its Eylea treatment for macular degeneration, the leading cause of blindness in the elderly.
With its more convenient dosing schedule, Eylea quickly stole market share from Roche Holding AG's Lucentis, and is expected to have sales this year of $1.8 billion. Regeneron's market capitalization, now $37 billion, has tracked Eylea's rise.

Regeneron hopes next summer to introduce alirocumab, which lowers cholesterol by blocking a protein called PCSK9. It is also being co-developed with Sanofi and expected to compete with a similar drug being developed by Amgen Inc. Analysts expect each of the drugs to generate annual sales of $2 billion or more, if approved.
But Michael Aberman, head of business development at Regeneron, said dupilumab may have even greater sales potential than alirocumab if it performs well in ongoing late-stage studies and is approved.
"It could be bigger," Aberman said, "because we believe we're getting at the crux of all these diseases" linked to allergies.


Regeneron's would-be blockbuster completes the allergic circle with Phase II success

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0		By Dian Garde	Comment	Forward	Twtter

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0	Column 1 0 Regeneron Vice President of Program Direction Neil Graham

Regeneron ($REGN) and partner Sanofi ($SNY) have notched another midstage milestone with their in-development allergy drug, a victory that affirms the hypothesis behind a treatment the companies believe could bring in billions.The drug, dupilumab, works by blocking interleukin-4 and interleukin-13, proteins tied to inflammation. In a Phase IIa proof-of-concept study, the injected treatment met its primary endpoint of reducing the size of nasal polyps and hit its secondary goals of improving sinusitis, nasal air flow and patient-reported symptoms, Regeneron said, also tamping down asthma in patients with that comorbidity.Those results build on a previous Phase IIb in which dupilumab significantly cleared the skin of patients with severe eczema (atopic dermatitis) and another midstage trial in which the drug substantially relieved asthma symptoms. The string of success supports Regeneron's unified theory of dupilumab: that each of the three diseases carries an underlying inflammatory link, and that blocking IL-4 and IL-13 can treat them all at once, Vice President Neil Graham said."There is growing recognition that patients suffering from one type of allergic disease often have additional allergic conditions" Graham said in a statement. "For example, many patients with chronic sinusitis with nasal polyps also have asthma or atopic dermatitis and vice versa. The new data reported today, together with prior Phase II data with dupilumab in asthma and atopic dermatitis, support the growing body of scientific evidence that these conditions may result from a core allergic inflammatory process driven by the IL-4/IL-13 pathway."Now Regeneron and Sanofi are mounting an ambitious Phase III effort, starting with eczema before moving on to asthma and, in light of the new Phase II results, chronic sinusitis with nasal polyps.The bull case for dupilumab lies both in its pan-allergic treatment potential and in the fact that the standard of care for each of its targets consists of corticosteroids, which can lead to unpleasant side effects and immune disruption. Those factors have Regeneron thinking big with the antibody, hoping it can win approval and blossom into a blockbuster."We have a lot of debate within the company as to which of our many programs is the most exciting, and a lot of people are voting on dupilumab," Regeneron Chief Scientific Officer George Yancopoulos told Reuters earlier this month.[/table]