The company has never submitted an IND to the FDA to enter into a Phase I study for NB111, or for any of their drug candidates, so implying they were "ostensibly getting rejected" is completely false and misleading.
It is quite clear from past PRs that all past work with Albany Molecular related to synthesis and supply for pre-clinical laboratory and animal testing and to refine their delivery methods.
True the company hasn't made it explicitly clear what the differences were in each PR, but a little nuanced reading goes a long way. Here is the history of press releases in chronological order:
NEMUS Bioscience, Inc. Signs Agreement With Albany Molecular Research Inc. (AMRI) to Manufacture Cannabinoid-Based Active Pharmaceutical Ingredients
02/08/2016
COSTA MESA, CA and ALBANY, NY -- (Marketwired) -- 02/08/16 -- NEMUS Bioscience, Inc. (OTCQB: NMUS), a biopharmaceutical company focused on the discovery, development, and commercialization of cannabinoid-based therapeutics for significant unmet medical needs, today announced an agreement with Albany Molecular Research Inc. (NASDAQ: AMRI) for the development and manufacture of NEMUS' proprietary cannabinoid-based active pharmaceutical ingredients. The agreement will capitalize on AMRI's process chemistry expertise in the synthesis and formulation of NEMUS' proprietary prodrug of tetrahydrocannabinol (THC). This molecule forms the basis of NB1111, NEMUS' compound in development for the treatment of glaucoma, and NB1222, for the management of chemotherapy-induced nausea and vomiting (CINV).
"Advancing our lead therapeutic candidates into the manufacturing stage is a major milestone for our company," commented Brian Murphy, M.D., CEO-CMO of NEMUS. "This permits us to move from testing prototypic formulations to having the ability to accumulate API-based data in pre-clinical and clinical studies, which is pivotal for submission to regulatory agencies."
"AMRI looks forward to working with NEMUS to bring this new class of cannabinoid-based therapies through the developmental process," said Christopher Conway, Senior Vice President of Discovery and Development Services at AMRI. "AMRI will focus on manufacturing synthetic versions of NEMUS' proprietary prodrug of THC at our U.S. Drug Enforcement Administration (DEA) approved facilities."
Dr. Murphy concluded: "Eye disease and the oncologic-related palliative care markets are in need of new classes of compounds to benefit patients. There is a significant need for better treatments for patients suffering from a variety of diseases including adverse events related to their cancer care. We are excited to collaborate with a highly-experienced manufacturer like AMRI, to bring new medications such as cannabinoid-based therapeutics, to these areas of significant unmet medical need."
____________________________________________________________________
Nemus Bioscience Announces Milestones in the Development of Fully Synthetic Clinical-Grade Active Pharmaceutical Ingredient (API) for Drug Candidates NB1111 and NB2111 and Formulation Contract with AMRI and Catalent Pharma Solutions
12/01/2016
COSTA MESA, CA / ACCESSWIRE / December 1, 2016 / NEMUS Bioscience, Inc. (NMUS) announced that work performed in conjunction with its API contract developer and manufacturer, Albany Molecular Research Inc. (NASDAQ:AMRI), resulted in a synthetic pathway to manufacture the clinical-grade proprietary prodrug tetrahydrocannabinol-valine-hemisuccinate (THCVHS), including the ability to scale-up production. In addition, the purity of the API achieved a standard exceeding FDA requirements of being at least 99.5% pure. Nemus has subsequently contracted with Catalent Pharma Solutions (Catalent) to begin formulation work associated with NB2111, the candidate product for managing chemotherapy-induced nausea and vomiting (CINV).
"Reliable and consistent API manufacturing is a major step necessary for human testing, regulatory approval and ultimate commercialization of a candidate molecule. The Nemus cannabinoid compounds of NB1111, which is intended for the treatment of glaucoma and NB2111, which is intended for managing chemotherapy-induced nausea and vomiting (CINV) both utilize the patented prodrug of THC as the active ingredient," commented Brian Murphy, M.D., M.B.A., CEO and Chief Medical Officer of Nemus. "In preparing for a pre-IND meeting with the FDA, the company is focused on formulation development of NB1111 and NB2111 to meet chemistry-manufacturing-controls (CMC) requirements of the FDA. We are working with Catalent in the formulation process to achieve a clinical-grade delivery of NB2111 in CINV."
"The company is exploring formulation options for the delivery of NB1111 into the eye. Nemus anticipates this process to be completed in the first quarter of 2017 resulting in a collaboration with an ocular drug delivery formulator that will help bring the candidate- glaucoma therapy forward to satisfy regulatory requirements for human testing," stated Dr. Murphy.
___________________________________________________________________
Nemus Bioscience Signs Development Agreement with Nanomerics to Advance Ocular Formulation of NB1111 for the Treatment of Glaucoma Using Proprietary Molecular Envelope Technology (MET)
03/20/2017
Download this Press Release (PDF 68 KB)
COSTA MESA, CA -- (Marketwired) -- 03/20/17 -- NEMUS Bioscience, Inc. (OTCQB: NMUS) announced that the company has signed a development agreement with Nanomerics Ltd. of the United Kingdom, to develop a topical ocular formulation of tetrahydrocannabinol-valine-hemisuccinate (THCVHS), the prodrug of THC, which is the active component of Nemus drug candidate NB1111 being developed for the treatment of glaucoma. The aim of the agreement is to conduct initial studies assessing the preparation of clinical-grade eye drops using the patented Molecular Envelope Technology (MET) developed by Nanomerics. Work under the agreement will commence on a future date to be determined by Nemus in connection with its development plans and corporate objectives.
"Historically, it has been challenging to formulate hydrophobic, or fat-soluble, cannabinoid molecules for efficient and predictable entry into the body, especially the eye," stated Brian Murphy, M.D., M.B.A., Nemus CEO and Chief Medical Officer. "Nemus has found the MET technology profile to be supportive of the work performed to-date using the more hydrophilic THCVHS which was designed to cross physiologic barriers more efficiently. Developing this formulation is an important step before conducting human studies."
"Nanomerics looks forward to working with Nemus on creating medicines that address the medical need for the improved treatment of glaucoma. Nemus, as the only cannabinoid company we are aware of with a complement of prodrugs and analogues of THC and CBD, is uniquely placed to potentially develop these for use in multiple forms of ocular disease," commented Professor Andreas Schätzlein, co-founder and CEO of Nanomerics. Nanomerics' CSO and co-founder Professor Ijeoma Uchegbu explained, "We feel that the MET platform will help NB1111 deliver in the clinic what has already been shown in several animal studies. Namely, penetration into multiple chambers of the eye, a non-opaque eye drop, and a neutral-pH at delivery to lower the risk of eye irritation which is an adverse event seen with some established therapies in glaucoma."
Dr. Murphy noted, "Should we find success in formulating NB1111 using Nanomerics' MET, we could also examine its application using our proprietary Nemus ophthalmic analogue of CBD (NB2222). Our company objective is to establish strategic partnerships utilizing a diverse cannabinoid-based ocular platform to address multiple types of eye disease."
___________________________________________________________________
UPDATE: Nemus Bioscience, Inc. Signs Agreement with Albany Molecular Research Inc. (AMRI) to Manufacture Cannabinoid-Based Active Pharmaceutical Ingredient for Glaucoma
08/01/2018
Long Beach, CA, Aug. 01, 2018 (GLOBE NEWSWIRE) -- Nemus Bioscience, Inc. (OTCQB: NMUS), focused on the development of cannabinoid-based therapeutics to address global medical indications, especially those of unmet medical need, today announced an agreement with Albany Molecular Research Inc. for the development and manufacture of Nemus' proprietary cannabinoid-based active pharmaceutical ingredients (API). The agreement will capitalize on AMRI's process chemistry expertise in the synthesis and formulation of Nemus' proprietary prodrug of tetrahydrocannabinol (THC). This molecule forms the basis of NB1111, Nemus' compound in development for the treatment of glaucoma.
"Advancing our lead therapeutic candidates into the API manufacturing stage is a major milestone for our company and is pivotal for initiating human studies," commented Brian Murphy, M.D., CEO-CMO of Nemus. "Cannabinoid-based therapies have the potential to revolutionize glaucoma therapy by not only lowering intraocular pressure, but by exerting a direct neuroprotective effect on the cells of the optic nerve, thereby preserving vision.”
"AMRI looks forward to working with Nemus to bring this new class of cannabinoid-based therapies through the developmental process," said Christopher Conway, Senior Vice President of Discovery and Development Services at AMRI. "AMRI will focus on manufacturing synthetic versions of Nemus' proprietary prodrug of THC at our U.S. Drug Enforcement Administration (DEA) approved facilities."
