Aradigm Announces the EMA Has Completed Its Validation of the MAA Submission

HAYWARD, Calif.–(BUSINESS WIRE)–Aradigm Corporation (NASDAQ: ARDM) (the “Company”) today
announced the completed formal validation by the European Medicines
Agency (EMA) of the Marketing Authorisation Application (MAA) for
Linhaliq for the treatment of non-cystic fibrosis bronchiectasis (NCFBE)
patients with chronic lung infections with Pseudomonas aeruginosa
(P. aeruginosa). The completion of the MAA validation is
commensurate with the start date of the review procedure on March 29,
2018.

The EMA review of the MAA for Linhaliq will be according to standard
timelines, with an opinion of the Committee for Medicinal Products for
Human Use (CHMP) expected within 210 days (less any clock-stops for the
applicant to provide answers to question(s) from the CHMP). After the
adoption of a CHMP opinion, a final decision regarding the MAA
assessment is carried out by the European Commission on Day 277 of the
procedure.

The validation of the MAA submission is a milestone event for Aradigm.
We look forward to working with EMA to gain approval for Linhaliq.

If approved by the European commission, Linhaliq will provide a
much-needed treatment for patients with NCFBE with chronic lung
infections with P. aeruginosa.

Additional Information about Linhaliq Phase 3 Trials and Regulatory
Development

Linhaliq, formerly known as Pulmaquin®, is composed of a mixture of
liposome encapsulated and unencapsulated ciprofloxacin. There are
currently no treatments approved for NCFBE patients to prevent and
reduce the number of PEs.

Linhaliq was evaluated in two Phase 3 studies (ORBIT-3 and ORBIT-4) to
determine its safety and effectiveness as a once-a-day inhaled
formulation for the chronic treatment of patients with NCFBE who have
chronic lung infections with P. aeruginosa.

Aradigm discussed the results of the Phase 3 studies at pre-submission
meetings with EMA in October and November 2017. Based on these
discussions, the statistical analysis of the results was changed from
the pre-specified plan to stratification based on sex and the frequency
of pulmonary exacerbations in the prior year, as the stratum for current
smokers contained a small number of subjects.

Further information about the analyses of the Phase 3 results is
presented at Aradigm’s website www.aradigm.com.

About Non-Cystic Fibrosis Bronchiectasis

NCFBE is a severe, chronic and rare disease characterized by abnormal
dilatation of the bronchi and bronchioles, frequently associated with
chronic lung infections. It is often a consequence of a vicious cycle of
inflammation, recurrent lung infections, and bronchial wall damage.
NCFBE represents an unmet medical need with high morbidity and mortality
that affects more than 150,000 people in the U.S. and over 200,000
people in Europe. There is currently no drug approved for the treatment
of this condition. NCFBE patients who have chronic infections with P.
aeruginosa have a 6.5-fold increase in hospitalization, three times
higher mortality, and a worse quality of life compared with those
without P. aeruginosa infections.

About Aradigm

Aradigm is an emerging specialty pharmaceutical company focused on the
development and commercialization of drugs for the prevention and
treatment of severe respiratory diseases. Aradigm has completed Phase 3
development of Linhaliq (an investigational proprietary formulation of
ciprofloxacin for inhalation) for the treatment of NCFBE. Aradigm’s
inhaled ciprofloxacin formulations including Linhaliq are also product
candidates for treatment of patients with cystic fibrosis and
non-tuberculous mycobacteria, and for the prevention and treatment of
high threat and bioterrorism infections, such as inhaled tularemia,
pneumonic plague, melioidosis, Q fever and inhaled anthrax.

More information about Aradigm can be found at www.aradigm.com.

Forward-Looking Statements

Except for the historical information contained herein, this news
release contains forward-looking statements that involve risk and
uncertainties, including the risk that the regulatory authorities may
not agree with our interpretation of the data from our clinical trials
of Linhaliq and may require us to conduct additional clinical trials;
Linhaliq may not receive regulatory approval or be successfully
commercialized, either as a result of the FDA’s or other regulatory
authorities’ decisions regarding labeling and other matters that could
affect its availability or commercial potential, or due to the other
risks detailed from time to time in the Company’s filings with the
Securities and Exchange Commission (SEC), including the Company’s Annual
Report on Form 10-K for the year ended December 31, 2017 filed with the
SEC on March 23, 2018, and the Company’s Quarterly Reports on Form 10-Q.

Aradigm, Pulmaquin and the Aradigm Logo are registered trademarks of
Aradigm Corporation. Linhaliq is a registered trademark of Grifols, S.A.

¹ Polverino E, Goeminne PC, McDonnell MJ, et al. European
Respiratory Society guidelines for the treatment of adult
bronchiectasis. Eur Respir J 2017; 50: 1700629 [https://ift.tt/2uO6E53].

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Romaco: Innojet IHD Series for Pharmaceuticals

Romaco Innojet’s first GMP-compliant hot melt coating device is specifically for use in the pharmaceutical industry. The IHD series for processing hot melt coatings can be supplied as a laboratory or pilot scale machine.

The IHD series is designed for coating and granulating pharmaceutical products with hot greases and waxes. GMP compliance was a key development priority for these CIP-capable devices, particularly regarding the validation of the cleaning processes. All sealing points, gaps and enclosed spaces were eliminated for this reason and flange connections reduced to a minimum.

The hot melt coating flows through straight tubes to prevent any build-up of product residues. All product-contacted surfaces inside the IHD devices are positioned in such a way that they are fully visible and suitable for swab testing. Once the device has been cleaned, it can be opened up quickly and easily for inspection. The Romaco Innojet IHD series successfully avoids cross-contamination thanks to the hygienic design with no dead spaces.

To allow precise and uniform heat distribution, the Innojet IHD is designed as a heatable monobloc integrating all functional components. The melting container, dosing unit and valve block are all included in the same thermal cycle, which means they do not have to be heated and insulated separately.

The compact hot melt coating devices are connected via a trace heated tube to the processing machines in the Romaco Innojet VENTILUS^® series whenever this is required by the application. The Innojet IHD feeds the hot melt with a pulsation-free dosing piston as standard, so that the coating is evenly applied to the product.

The central bottom spray nozzle on the Innojet machine enables both the temperature and the size of the droplets with which the product particles are coated to be precisely defined. The Romaco Innojet air flow bed technology ensures homogeneous and controllable flow conditions in the container of the processing machines. The laboratory scale version of the hot melt coating device (Innojet IHD5) is designed to handle batches of up to 5 L while the pilot scale machine (Innojet IHD50) can process up to 50 L.

Innojet’s IHD technology lets pharmaceutical manufacturers reap the previously unattainable benefits of hot melt coatings. Unlike aqueous alternatives, hot melt coatings contain no solvents which would have to be evaporated again after they have been sprayed on. Hot melt coatings solidify directly on the product, resulting in up to 85% shorter processing times. Less spray is required for hot melt coating processes because the formulations are solvent-free.

With no need to heat the air in order to dry the product, energy efficiency is improved. Hot melt coating is an economical and efficient production process, and is versatile, for example for moisture barriers, taste masks or delayed API release.

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Thermal analysis in practice: tutorial examples

Before you can begin to develop a method, you must be clear about the information and the quality of the data you want to obtain from a sample. This very often determines the possible techniques and methods that can be used…

The development and validation of methods is of major importance in today’s quality assurance systems in research and production. The starting point is usually a draft method that is then optimised and validated in several iterative steps. The final result is a validated method that can be used as part of a standard operating procedure (SOP). The development and validation of a measurement procedure is time-consuming and costly. This means it is important to start right from the beginning with a good draft method. The following sections systematise the development of thermal analysis methods and discuss the most important aspects involved.

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Roche acquires Inception neuroscience program

Published 05 April 2018

Roche has acquired the Inception 5 program, which is focused on regenerative therapies for multiple sclerosis.

The acquisition is the culmination of a June 2014 alliance between Inception and Roche to discover and develop novel small molecules that promote remyelination of nerve fibers damaged during the progression of multiple sclerosis.

Versant Ventures backed the project with equity financing, and Roche provided research funding to secure an option to acquire a specific program upon delivery of an IND-enabling package. The specific target of the acquired program is not disclosed.

During the following 3.5 years, Inception scientists translated discoveries made at the University of California, San Francisco, aimed at the identification and validation of novel targets for remyelination, into a development-stage small molecule program for multiple sclerosis.

Versant investment team chair and managing directorBrad Bolzon said: “It is gratifying to see another successful outcome within Versant’s Discovery Engine network.

“We continue to leverage collaborative business models with pharma partners, especially in emerging fields such as this. We thank Roche for their confidence in the potential of our partnership to produce an entirely new class of therapeutics for multiple sclerosis and other demyelinating diseases.”

Inception Sciences CEO Peppi Prasit said: “Our Inception scientists once again demonstrated their ability to effectively translate foundational academic discoveries into high-quality drug candidates.

“ This achievement resulted from access to cutting-edge academic research, a proven team of drug hunters with domain expertise, and support from our venture capital and pharma partners.”

Following the acquisition of the Inception 5 program, Versant plans to launch Pipeline Therapeutics, a successor company led by the same operating team and a broadened network of academic founders. Pipeline will build an expanded platform to identify the next generation of neuro-regenerative therapies.

The new company’s leadership team includes Drs. Brian Stearns and Daniel Lorrain, who co-led translational work on the Inception 5 remyelination program. Versant’s leadership for the formation, financing and launch of Pipeline will be assumed by Clare Ozawa, Versant managing director.

“We are very excited to announce the creation of Pipeline Therapeutics and look forward to pursuing other therapeutic approaches that can promote functional recovery in neurological diseases,” said Dr. Stearns.

The successor company is solely backed by Versant and expects to seek syndicate financing and industry partners by 2019.

“Based on the continued progress in the field, we are now positioned to pursue drug candidates that invoke the natural repair processes in several nervous system cell types,” said Dr. Ozawa. “We aim to create the leading company in the field and to build a portfolio of therapies for several neurodegenerative disorders that currently lack effective treatments.”

Source: Company Press Release

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New Romaco Innojet IHD Series at ACHEMA 2018

Romaco Innojet has just come up with the first GMP compliant hot melt coating device specifically for use in the pharmaceutical industry. The IHD series for processing hot melt coatings can be supplied as a laboratory or pilot scale machine. 

The IHD series from Romaco Innojet was specially designed for coating and granulating pharmaceutical products with hot greases and waxes. GMP compliance was a key development priority for these CIP capable devices, particularly regarding the validation of the cleaning processes. All sealing points, gaps and enclosed spaces were eliminated for this reason and flange connections reduced to a minimum. The hot melt coating flows through straight tubes to prevent any build-up of product residues. All product-contacted surfaces inside the IHD devices are positioned in such a way that they are fully visible and suitable for swab testing. Once the device has been cleaned, it can be opened up quickly and easily for inspection. The Romaco Innojet IHD series successfully avoids cross-contamination thanks to the hygienic design with no dead spaces.

Presentation from Kai Koch, Technical Director, Romaco Innojet on the subject of hot melt coating at the ACHEMA press preview from March 14, 2018:

To allow precise and uniform heat distribution, the Innojet IHD was designed as a heatable monobloc integrating all functional components. The melting container, dosing unit and valve block are all included in the same thermal cycle, which means they do not have to be heated and insulated separately. The compact hot melt coating devices are connected via a trace heated tube to the processing machines in the Romaco Innojet VENTILUS® series whenever this is required by the application. The Innojet IHD feeds the hot melt with a pulsation-free dosing piston as standard, so that the coating is applied to the product absolutely evenly. The central bottom spray nozzle on the Innojet machine enables both the temperature and the size of the droplets with which the product particles are coated to be precisely defined. The Romaco Innojet air flow bed technology ensures homogeneous and controllable flow conditions in the container of the processing machines. The laboratory scale version of the hot melt coating device (Innojet IHD 5) is designed to handle batches of up to 5 litres while the pilot scale machine (Innojet IHD 50) can process up to 50 litres.

Benefits of hot melt coated formulations

Innojet’s IHD technology lets pharmaceutical manufacturers reap the previously unattainable benefits of hot melt coatings. Unlike aqueous alternatives, hot melt coatings contain no solvents which would have to be evaporated again after they have been sprayed on. Hot melt coatings solidify directly on the product, resulting in up to 85 percent shorter processing times. Less spray is required for hot melt coating processes because the formulations are solvent-free. What’s more, since there is no need to heat the air in order to dry the product, energy efficiency is improved. Hot melt coating is not only an extremely economical and efficient production process; it is also very versatile, for example for moisture barriers, taste masks or delayed API release.

On show at ACHEMA in Frankfurt/Main (Germany) from June 11 to 15, 2018 (Messe Frankfurt, Hall 3.0, Stand B49).

More info:

www.romaco.com

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New Haven’s Arvinas Raises $55M To Begin Cancer Trials