Aimmune Therapeutics Announces Additional $200 Million Equity Investment by Nestlé Health Science
BRISBANE, Calif.–(BUSINESS WIRE)–Aimmune Therapeutics, Inc. (Nasdaq: AIMT), a biopharmaceutical firm growing and commercializing remedies for probably life-threatening meals allergy symptoms, at this time introduced that Nestlé Well being Science will make an extra fairness funding in Aimmune of $200 million, bringing Nestlé’s complete funding in Aimmune to this point to $473 million.
“Nestlé Well being Science has been an essential fairness investor and strategic companion to Aimmune since we entered into our unique collaboration in 2016, and we’re grateful for his or her ongoing dedication towards our mutual aim of growing revolutionary therapies for meals allergy symptoms,” stated Jayson Dallas, M.D., President and CEO of Aimmune Therapeutics. “This extra capital strengthens our monetary place as we put together to launch PALFORZIA™, the primary FDA-approved medication for peanut allergy within the U.S. As well as, this capital will assist fund the continued development of our pipeline, together with conducting medical trials of AIMab7195 which we just lately in-licensed from Xencor.”
The Nestlé Well being Science funding consists of the acquisition of 1,000,000 shares of Aimmune widespread inventory and 525,634 shares of convertible most well-liked inventory, convertible on a one-for-ten shares of widespread inventory foundation in sure circumstances and topic to sure limitations. The convertible most well-liked inventory has a liquidation desire of $zero.0001 per share, doesn’t have any voting rights, and has no said dividend. In reference to this transaction, sure phrases of Aimmune’s agreements with Nestlé Well being Science have been prolonged by one yr till November 11, 2021.
“Our collaboration with Aimmune aligns with our mission to offer revolutionary dietary well being options which are supported by science and analysis,” stated Greg Behar, CEO of Nestlé Well being Science. “We’re impressed with the progress Aimmune has made because it prepares to launch PALFORZIA, the primary drug accredited by the FDA for any type of meals allergy. As a part of our ongoing dedication to the development of science-based dietary well being options, our additional funding in Aimmune is meant to assist guarantee PALFORZIA’s longer-term business success and permit Aimmune to proceed making important improvement advances within the discipline of meals allergy remedies.”
Upon closing of the fairness funding, Aimmune will obtain a cost of $200 million in reference to Nestlé Well being Science’s buy of 1,000,000 newly issued shares of Aimmune’s widespread inventory at $31.97 per share, primarily based on the latest five-day quantity weighted common inventory value and 525,634 shares of convertible most well-liked inventory priced at $319.675 per share. The popular inventory is convertible to widespread inventory on a one-for-ten foundation. After the completion of the transaction, Nestlé Well being Science’s complete investments in Aimmune will correspond to possession of 19.9% of Aimmune’s excellent widespread inventory and voting energy, and 25.6% total stake within the firm’s fully-diluted capitalization. The businesses anticipate to shut the fairness funding on February 7, 2020, topic to satisfaction of standard and customary closing circumstances.
PALFORZIA is an oral immunotherapy indicated for the mitigation of allergic reactions, together with anaphylaxis, that will happen with unintended publicity to peanut. PALFORZIA is accredited to be used in sufferers with a confirmed prognosis of peanut allergy. Preliminary Dose Escalation could also be administered to sufferers aged four by 17 years. Up-Dosing and Upkeep could also be continued in sufferers four years of age and older.
PALFORZIA is for use together with a peanut-avoidant weight loss plan.
Limitations of Use: Not indicated for the emergency therapy of allergic reactions, together with anaphylaxis.
IMPORTANT SAFETY INFORMATION
PALFORZIA could cause anaphylaxis, which can be life threatening and might happen at any time throughout PALFORZIA remedy.
Prescribe injectable epinephrine, instruct and prepare sufferers on its applicable use, and instruct sufferers to hunt speedy medical care upon its use.
Don’t administer PALFORZIA to sufferers with uncontrolled bronchial asthma.
Dose modifications could also be crucial following an anaphylactic response.
Observe sufferers throughout and after administration of the Preliminary Dose Escalation and the primary dose of every Up-Dosing degree, for at the least 60 minutes.
PALFORZIA is accessible solely by a restricted program referred to as the PALFORZIA REMS.
PALFORZIA is contraindicated in sufferers with uncontrolled bronchial asthma, or with a historical past of eosinophilic esophagitis and different eosinophilic gastrointestinal illness.
WARNINGS AND PRECAUTIONS
PALFORZIA could cause anaphylaxis, which can be life threatening. PALFORZIA is accessible solely by a restricted program beneath a Danger Analysis and Mitigation Technique (REMS) referred to as the PALFORZIA REMS due to the chance of anaphylaxis. Solely prescribers, healthcare settings, pharmacies, and sufferers licensed and enrolled within the REMS Program can prescribe, obtain, dispense or administer PALFORZIA.
Anaphylaxis has been reported throughout all phases of PALFORZIA dosing, together with Upkeep and in topics who’ve undergone really useful Up-Dosing and dose modification procedures.
Don’t provoke PALFORZIA therapy in a affected person who has had extreme or life-threatening anaphylaxis throughout the earlier 60 days. PALFORZIA is probably not appropriate for sufferers with sure medical circumstances that will scale back the power to outlive anaphylaxis, together with however not restricted to markedly compromised lung operate, extreme mast cell dysfunction, or heart problems. As well as, PALFORZIA is probably not appropriate for sufferers taking medicines that may inhibit or potentiate the consequences of epinephrine.
All Preliminary Dose Escalation doses and the primary dose of every Up-Dosing degree have to be administered in a licensed well being care setting.
Sufferers could also be extra more likely to expertise allergic reactions following PALFORZIA administration within the presence of cofactors similar to train, scorching water publicity, intercurrent sickness (e.g., viral an infection), or fasting. Different potential cofactors could embody menstruation, sleep deprivation, nonsteroidal anti-inflammatory drug use, or uncontrolled bronchial asthma. Sufferers needs to be proactively recommended concerning the potential for the elevated threat of anaphylaxis within the presence of those cofactors. If doable, modify the time of dosing to keep away from these cofactors. If it isn’t doable to keep away from these cofactors, contemplate withholding PALFORZIA briefly.
Uncontrolled bronchial asthma is a threat issue for a severe end result, together with loss of life, in anaphylaxis. Guarantee sufferers with bronchial asthma have their bronchial asthma beneath management previous to initiation of PALFORZIA.
PALFORZIA needs to be briefly withheld if the affected person is experiencing an acute bronchial asthma exacerbation. Following decision of the exacerbation, resumption of PALFORZIA needs to be undertaken cautiously. Re-evaluate sufferers who’ve recurrent bronchial asthma exacerbations and contemplate discontinuation of PALFORZIA.
Eosinophilic Gastrointestinal Illness
Discontinue PALFORZIA and contemplate a prognosis of eosinophilic esophagitis in sufferers who expertise extreme or persistent gastrointestinal signs, together with dysphagia, vomiting, nausea, gastroesophageal reflux, chest ache, or belly ache.
Gastrointestinal Hostile Reactions
Gastrointestinal antagonistic reactions had been generally reported in PALFORZIA-treated topics, and dose modification needs to be thought-about for sufferers who report these reactions. For extreme or persistent gastrointestinal signs contemplate a prognosis of eosinophilic esophagitis.
The most typical antagonistic occasions reported in topics handled with PALFORZIA (incidence ≥ 5% and ≥ 5% than placebo) are belly ache, vomiting, nausea, oral pruritus, oral paresthesia, throat irritation, cough, rhinorrhea, sneezing, throat tightness, wheezing, dyspnea, pruritus, urticaria, anaphylactic response, and ear pruritus.
Please see full Prescribing Info, together with Boxed WARNING, and Treatment Information at www.PALFORZIA.com.
For extra details about PALFORZIA, please name 1-844-PALFORZ (1-844-725-3679) or go to www.PALFORZIA.com.
Aimmune Therapeutics, Inc. is a biopharmaceutical firm that aspires to turn into the worldwide chief in growing healing therapies and options for sufferers with meals allergy symptoms. With a mission to enhance the lives of individuals with meals allergy symptoms, Aimmune is growing and commercializing oral remedies for probably life-threatening meals allergy symptoms. The Firm’s Characterised Oral Desensitization ImmunoTherapy (CODIT™) strategy is meant to offer significant ranges of safety towards allergic reactions ensuing from unintended publicity to meals allergens by desensitizing sufferers with outlined, exact quantities of key allergens. Aimmune has one FDA-approved medication for peanut allergy and different investigational therapies in improvement to deal with different meals allergy symptoms. For extra data, please go to www.aimmune.com.
Statements contained on this press launch relating to issues that aren’t historic info are “forward-looking statements” throughout the that means of the Personal Securities Litigation Reform Act of 1995. As a result of such statements are topic to dangers and uncertainties, precise outcomes could differ materially from these expressed or implied by such forward-looking statements. Such statements embody, however will not be restricted to, statements relating to: Aimmune’s expectations relating to the potential advantages of PALFORZIA; Aimmune’s expectations relating to the potential business launch of PALFORZIA; and Aimmune’s expectations relating to potential functions of the CODIT strategy to treating life-threatening meals allergy symptoms. Dangers and uncertainties that contribute to the unsure nature of the forward-looking statements embody: the expectation that Aimmune will want further funds to finance its operations; Aimmune’s dependence on the success of PALFORZIA; Aimmune’s skill to construct a business discipline group and distribution community; the diploma of acceptance of PALFORZIA amongst physicians, sufferers, healthcare payors, affected person advocacy teams and the final medical neighborhood; Aimmune’s skill to acquire favorable protection and reimbursement from third-party payors for PALFORZIA; Aimmune’s reliance on third events for the manufacture of PALFORZIA; Aimmune’s skill to implement and adjust to the REMS for PALFORZIA; doable regulatory developments in the USA and international international locations; and Aimmune’s skill to draw and retain senior administration personnel. These and different dangers and uncertainties are described extra absolutely in Aimmune’s most up-to-date filings with the Securities and Trade Fee, together with its Quarterly Report on Kind 10-Q for the quarter ended September 30, 2019. All forward-looking statements contained on this press launch converse solely as of the date on which they had been made. Aimmune undertakes no obligation to replace such statements to mirror occasions that happen or circumstances that exist after the date on which they had been made.
This press launch considerations PALFORZIA (AR101), which has been accredited for advertising by the FDA in the USA and has not been accredited for advertising by the EMA or Swissmedic. AR101 in Europe is presently restricted to investigational use, and no illustration is made as to its security or effectiveness for the needs for which it’s being investigated.
AIMab7195 TM, PALFORZIA™, AIMMUNE™, AIMMUNE THERAPEUTICS™ and CODIT™ are logos of Aimmune Therapeutics, Inc.